FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FEMTEX TAMPONS AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS; CONSUMER PACKAGES AND BULK PACKAGES
K Number: K023479
·
Decision Nov 26, 2002
Classifications
1
FEI Numbers
92
Registration Numbers
93
Same Product Code
188
Applicant Total
11
Review Days
40
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Basic Information
- Device Name
- FEMTEX TAMPONS AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS; CONSUMER PACKAGES AND BULK PACKAGES
- K Number
- K023479
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5470
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- First Quality Hygienic, Inc.
- Date Received
- October 17, 2002
- Decision Date
- November 26, 2002
- Product Code
- HEB
- 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 |
|---|---|---|---|
| HEB | Tampon, Menstrual, Unscented | FDA class 2 | Obstetrics/Gynecology |
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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 |
| K050067 | FEMTEX AND PRIVATE LABEL SCENTED PLASTIC APPLICATOR TAMPONS | Feb 1, 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 |
| 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 |