FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PLAYTEX ULTIMATES UNSCENTED AND SCENTED TAMPONS
K Number: K904937
·
Decision Mar 15, 1991
Classifications
1
FEI Numbers
92
Registration Numbers
93
Same Product Code
188
Applicant Total
17
Review Days
134
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- PLAYTEX ULTIMATES UNSCENTED AND SCENTED TAMPONS
- K Number
- K904937
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5470
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Playtex Family Products, Inc.
- Date Received
- November 1, 1990
- Decision Date
- March 15, 1991
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HEB), ordered by most recent decision date.
Livi Device
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Unscented menstrual three-piece applicator tampon
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital Tampons
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SABA Tampons
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Playtex Family Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K941196 | PLATEX TAMPONS MODEL NUMBER 07094 | Apr 19, 1994 | Substantially Equivalent |
| K940821 | PLAYTEX TAMPONS #04994 UNSCENTED & SCENTED | Mar 25, 1994 | Substantially Equivalent |
| K936189 | PLAYTEX ULTIMATES TAMPONS/UNSCENTED AND SCENTED | Mar 7, 1994 | Substantially Equivalent |
| K932907 | PLAYTEX ULTIMATES TAMPONS | Mar 7, 1994 | Substantially Equivalent |
| K935276 | PLAYTEX NON-DEODORANT TAMPONS, PLAYTEX DEODORANT TAMPONS | Mar 7, 1994 | Substantially Equivalent |
| K932909 | PLAYTEX ULTIMATES TAMPONS | Mar 7, 1994 | Substantially Equivalent |
| K934083 | PLAYTEX ULTIMATES TAMPONS | Mar 7, 1994 | Substantially Equivalent |
| K922834 | TAMPONS, NATURAL ODOR PROT. VARIOUS ABSORBENCY | Sep 1, 1993 | Substantially Equivalent |
| K924279 | PLAYTEX FLUSHABLE TAMPONS, REGULAR, SUPER, SUPER + | May 21, 1993 | Substantially Equivalent |
| K914438 | PLAYTEX ULTIMATES UNSCENTED/SCENTED TAMPONS | Jan 2, 1992 | Substantially Equivalent |