The following data is part of a premarket notification filed by Intl. Playtex, Inc. with the FDA for Playtex Slender Reg. Tampons & Deodorant Tampons.
Device ID | K852063 |
510k Number | K852063 |
Device Name: | PLAYTEX SLENDER REG. TAMPONS & DEODORANT TAMPONS |
Classification | Tampon, Menstrual, Unscented |
Applicant | INTL. PLAYTEX, INC. 215 COLLEGE RD. P.O. BOX 728 Paramus, NJ 07652 |
Contact | Irwin Butensky |
Correspondent | Irwin Butensky INTL. PLAYTEX, INC. 215 COLLEGE RD. P.O. BOX 728 Paramus, NJ 07652 |
Product Code | HEB |
CFR Regulation Number | 884.5470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-05-13 |
Decision Date | 1985-05-22 |