The following data is part of a premarket notification filed by Playtex Family Products, Inc. with the FDA for Playtex Tampons, Non-deodorant/deodorant.
Device ID | K893725 |
510k Number | K893725 |
Device Name: | PLAYTEX TAMPONS, NON-DEODORANT/DEODORANT |
Classification | Tampon, Menstrual, Unscented |
Applicant | PLAYTEX FAMILY PRODUCTS, INC. 215 COLLEGE RD. P.O. BOX 728 Paramus, NJ 07653 |
Contact | Butensky, Phd. |
Correspondent | Butensky, Phd. PLAYTEX FAMILY PRODUCTS, 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 | 1989-05-17 |
Decision Date | 1989-08-04 |