The following data is part of a premarket notification filed by Tampax, Inc. with the FDA for Tampax Deodorant Tampons.
Device ID | K810143 |
510k Number | K810143 |
Device Name: | TAMPAX DEODORANT TAMPONS |
Classification | Tampon, Menstrual, Scented, Deodorized |
Applicant | TAMPAX, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | HIL |
CFR Regulation Number | 884.5460 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-01-21 |
Decision Date | 1981-03-04 |