FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
O.B. APPLICATOR TAMPONS
K Number: K953638
·
Decision Oct 20, 1995
Classifications
1
FEI Numbers
26
Registration Numbers
27
Same Product Code
83
Applicant Total
45
Review Days
77
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Basic Information
- Device Name
- O.B. APPLICATOR TAMPONS
- K Number
- K953638
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5460
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Personal Products Co.
- Date Received
- August 4, 1995
- Decision Date
- October 20, 1995
- 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 Personal Products Co.
| K Number | Device Name | ||
|---|---|---|---|
| K070545 | K-Y BRAND WARMING LIQUID | Mar 23, 2007 | Substantially Equivalent |
| K062796 | K-Y BRAND INTRIGUE | Dec 8, 2006 | Substantially Equivalent |
| K010365 | ORTHO CONTROL FEMALE URINARY CONTROL DEVICE | Apr 30, 2001 | Substantially Equivalent |
| K990536 | O.B. TAMPON | Aug 31, 1999 | Substantially Equivalent |
| K991118 | O.B. APPLICATOR TAMPONS, O.B. TAMPONS | Jun 29, 1999 | Substantially Equivalent |
| K974629 | O.B. APPLICATOR AND NON-APPLICATOR TAMPONS | Feb 10, 1998 | Substantially Equivalent |
| K971589 | REACH ANTIBACTERIAL TOOTHBRUSH | Jul 24, 1997 | Substantially Equivalent |
| K970954 | O.B. APPLICATOR TAMPONS | Jun 10, 1997 | Substantially Equivalent |
| K961119 | CAREFREE PANTYLINERS | Apr 17, 1996 | Substantially Equivalent |
| K941863 | O.B. TAMPON | Jun 27, 1994 | Substantially Equivalent |