The following data is part of a premarket notification filed by Tambrands, Inc. with the FDA for Tampax Compak, Compact Plastic Appli. Super Tampon.
Device ID | K880022 |
510k Number | K880022 |
Device Name: | TAMPAX COMPAK, COMPACT PLASTIC APPLI. SUPER TAMPON |
Classification | Tampon, Menstrual, Scented, Deodorized |
Applicant | TAMBRANDS, INC. BRIDGE & SPRINGFIELD STREETS Palmer, MA 01069 |
Contact | Staab, Phd |
Correspondent | Staab, Phd TAMBRANDS, INC. BRIDGE & SPRINGFIELD STREETS Palmer, MA 01069 |
Product Code | HIL |
CFR Regulation Number | 884.5460 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-01-05 |
Decision Date | 1988-03-02 |