The following data is part of a premarket notification filed by Tambrands, Inc. with the FDA for Tampax Ultrafit Panty Shields, Deodorant.
Device ID | K884951 |
510k Number | K884951 |
Device Name: | TAMPAX ULTRAFIT PANTY SHIELDS, DEODORANT |
Classification | Pad, Menstrual, Scented |
Applicant | TAMBRANDS, INC. BRIDGE & SPRINGFIELD STREETS Palmer, MA 01069 |
Contact | Davis, Phd |
Correspondent | Davis, Phd TAMBRANDS, INC. BRIDGE & SPRINGFIELD STREETS Palmer, MA 01069 |
Product Code | HHL |
CFR Regulation Number | 884.5425 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-11-25 |
Decision Date | 1989-01-10 |