FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS
K Number: K050067
·
Decision Feb 1, 2005
Classifications
1
FEI Numbers
26
Registration Numbers
27
Same Product Code
83
Applicant Total
11
Review Days
20
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Basic Information
- Device Name
- FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS
- K Number
- K050067
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5460
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- First Quality Hygienic, Inc.
- Date Received
- January 12, 2005
- Decision Date
- February 1, 2005
- Product Code
- HIL
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HIL | Tampon, Menstrual, Scented, Scented-Deodorized | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HIL), ordered by most recent decision date.
ONTEX AND OTHERS PROPRIETARY NAMES
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PLAYTEX (SCENTED AND UNSCENTED) SPORT FRESH BALANCE TAMPONS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PLAYTEX GENTLE GLIDE SCENTED TAMPONS AND PLAYTEX GENTLE GLIDE UNSCENTED TAMPONS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PLAYTEX SPORT (UNSCENTED) ,(SCENTED) WITH ODORSHIELD
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
TAMPAX PEARL PLASTIC APPLICATOR TAMPONS, SCENTED AND UNSCENTED
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PLAYTEX GENTILE GLIDE, PLAYTEX GENTILE GLIDE MULTIPACK TAMPONS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by First Quality Hygienic, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K161877 | Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, RegularOpal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super, Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super Pl | Aug 5, 2016 | Substantially Equivalent |
| K151470 | Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light Absorbency; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Regular & Super; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Plus; Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Absorbency | Nov 2, 2015 | Substantially Equivalent |
| K051446 | FEMTEX AND PRIVATE LABEL OPAL FRESH SCENTED PLASTIC APPLICATOR TAMPONS | Jul 14, 2005 | Substantially Equivalent |
| K050660 | FEMTEX AND PRIVATE LABEL PLASTIC APPLICATOR TAMPONS | May 12, 2005 | Substantially Equivalent |
| K032173 | FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS | Sep 3, 2003 | Substantially Equivalent |
| K031067 | FEMTEX JUNIOR/SLENDER REGULAR OPEN-END TAMPONS | Jul 14, 2003 | Substantially Equivalent |
| K023479 | FEMTEX TAMPONS AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS; CONSUMER PACKAGES AND BULK PACKAGES | Nov 26, 2002 | Substantially Equivalent |
| K963034 | FEMTEX GENTLE TOUCH TAMPONS | Nov 1, 1996 | Substantially Equivalent |
| K963032 | FREE CHOICE | Oct 11, 1996 | Substantially Equivalent |
| K920238 | PRIVATE LABELS AND FEMTEX | Aug 2, 1993 | Substantially Equivalent |