The following data is part of a premarket notification filed by Tambrands, Inc. with the FDA for Tampax Tampon, Regular Absorbency.
Device ID | K924303 |
510k Number | K924303 |
Device Name: | TAMPAX TAMPON, REGULAR ABSORBENCY |
Classification | Tampon, Menstrual, Unscented |
Applicant | TAMBRANDS, INC. BRIDGE & SPRINGFIELD STREETS Palmer, MA 01069 |
Contact | Barbara M Davis |
Correspondent | Barbara M Davis TAMBRANDS, INC. BRIDGE & SPRINGFIELD STREETS Palmer, MA 01069 |
Product Code | HEB |
CFR Regulation Number | 884.5470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-08-05 |
Decision Date | 1993-07-29 |