The following data is part of a premarket notification filed by Playtex, Inc. with the FDA for Playtex Tampons #03498.
| Device ID | K980478 |
| 510k Number | K980478 |
| Device Name: | PLAYTEX TAMPONS #03498 |
| Classification | Tampon, Menstrual, Unscented |
| Applicant | PLAYTEX, INC. 215 COLLEGE RD. P.O. BOX 728 Paramus, NJ 07653 |
| Contact | Mark Rosengarten |
| Correspondent | Mark Rosengarten PLAYTEX, INC. 215 COLLEGE RD. P.O. BOX 728 Paramus, NJ 07653 |
| Product Code | HEB |
| CFR Regulation Number | 884.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-06 |
| Decision Date | 1998-04-03 |
| Summary: | summary |