The following data is part of a premarket notification filed by Intl. Playtex, Inc. with the FDA for Pads, Mini, Maxi Deodorant.
Device ID | K782111 |
510k Number | K782111 |
Device Name: | PADS, MINI, MAXI DEODORANT |
Classification | Pad, Menstrual, Scented |
Applicant | INTL. PLAYTEX, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | HHL |
CFR Regulation Number | 884.5425 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-12-18 |
Decision Date | 1979-01-08 |