FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS
K Number: K983381
·
Decision Oct 19, 1998
Classifications
1
FEI Numbers
92
Registration Numbers
93
Same Product Code
188
Applicant Total
14
Review Days
24
Basic Information
- Device Name
- VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS
- K Number
- K983381
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5470
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Paragon Trade Brands, Inc.
- Date Received
- September 25, 1998
- Decision Date
- October 19, 1998
- 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 Paragon Trade Brands, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K981953 | VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS | Aug 18, 1998 | Substantially Equivalent |
| K962954 | DEODORANT MAXI PAD | Oct 10, 1996 | Substantially Equivalent |
| K962962 | DEODORANT PANTY LINER | Oct 10, 1996 | Substantially Equivalent |
| K962953 | DEODORANT PANTY SHIELD | Oct 10, 1996 | Substantially Equivalent |
| K953333 | MENSTRUAL TAMPON | Dec 6, 1995 | Substantially Equivalent |
| K953667 | UNSCENTED CURVED ULTRATHIN MAXI PADS | Nov 1, 1995 | Substantially Equivalent |
| K953668 | UNSCENTED ULTRATHIN MAXI PAD | Nov 1, 1995 | Substantially Equivalent |
| K953553 | UNSCENTED MENSTRAL PAD | Oct 27, 1995 | Substantially Equivalent |
| K953517 | UNSCENTED MENSTRUAL PAD | Oct 26, 1995 | Substantially Equivalent |
| K953700 | UNSCENTED CURVED MAXI PAD | Sep 27, 1995 | Substantially Equivalent |