The following data is part of a premarket notification filed by Playtex Products, Inc. with the FDA for Platex Gentle Glide, Silk Glide, Slimfits, Soft Comfort And Portables Tampons.
Device ID | K982383 |
510k Number | K982383 |
Device Name: | PLATEX GENTLE GLIDE, SILK GLIDE, SLIMFITS, SOFT COMFORT AND PORTABLES 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 | 1998-07-08 |
Decision Date | 1998-08-19 |
Summary: | summary |