The following data is part of a premarket notification filed by Playtex Products, Inc. with the FDA for Playtex Tampons #14897/playtex Gentle Glide,silk Glide, Slimfits,soft Comfort And Portables Tampons.
| Device ID | K971979 |
| 510k Number | K971979 |
| Device Name: | PLAYTEX TAMPONS #14897/PLAYTEX GENTLE GLIDE,SILK GLIDE, SLIMFITS,SOFT COMFORT AND PORTABLES TAMPONS |
| Classification | Speculum, Vaginal, Nonmetal |
| Applicant | PLAYTEX PRODUCTS, INC. 215 COLLEGE RD. P.O. BOX 728 Paramus, NJ 07652 |
| Contact | Mark E Rosengarten |
| Correspondent | Mark E Rosengarten PLAYTEX PRODUCTS, INC. 215 COLLEGE RD. P.O. BOX 728 Paramus, NJ 07652 |
| Product Code | HIB |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-29 |
| Decision Date | 1997-09-26 |
| Summary: | summary |