The following data is part of a premarket notification filed by Playtex Products, Inc. with the FDA for Playtex Tampons #11197, Playtex Gentle Glide, Soft Comfort And Slimfits Tampons.
| Device ID | K971547 |
| 510k Number | K971547 |
| Device Name: | PLAYTEX TAMPONS #11197, PLAYTEX GENTLE GLIDE, SOFT COMFORT AND SLIMFITS TAMPONS |
| Classification | Tampon, Menstrual, Scented, Deodorized |
| Applicant | PLAYTEX PRODUCTS, INC. 215 COLLEGE RD. P.O. BOX 728 Paramus, NJ 07652 |
| Contact | Mark Rosengarten |
| Correspondent | Mark Rosengarten PLAYTEX PRODUCTS, INC. 215 COLLEGE RD. P.O. BOX 728 Paramus, NJ 07652 |
| Product Code | HIL |
| CFR Regulation Number | 884.5460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-28 |
| Decision Date | 1997-06-19 |
| Summary: | summary |