The following data is part of a premarket notification filed by Paragon Trade Brands, Inc. with the FDA for Various Trade Tampons Sold Under Private Labels.
| Device ID | K983381 |
| 510k Number | K983381 |
| Device Name: | VARIOUS TRADE TAMPONS SOLD UNDER PRIVATE LABELS |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | PARAGON TRADE BRANDS, INC. 73 FRANKLIN TPK. Allendale, NJ 07401 |
| Contact | Robert J Staab |
| Correspondent | Robert J Staab PARAGON TRADE BRANDS, INC. 73 FRANKLIN TPK. Allendale, NJ 07401 |
| Product Code | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-25 |
| Decision Date | 1998-10-19 |
| Summary: | summary |