The following data is part of a premarket notification filed by Tambrands, Inc. with the FDA for Maxithins Panty Shields, Deodorant.
Device ID | K884445 |
510k Number | K884445 |
Device Name: | MAXITHINS PANTY SHIELDS, DEODORANT |
Classification | Pad, Menstrual, Scented |
Applicant | TAMBRANDS, INC. BRIDGE & SPRINGFIELD STREETS Palmer, MA 01069 |
Contact | Gressel, Phd |
Correspondent | Gressel, 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 | 1988-10-21 |
Decision Date | 1988-12-05 |