The following data is part of a premarket notification filed by Tambrands, Inc. with the FDA for Tampax Closed-end Flushable Tampon, Super Plus.
Device ID | K870360 |
510k Number | K870360 |
Device Name: | TAMPAX CLOSED-END FLUSHABLE TAMPON, SUPER PLUS |
Classification | Tampon, Menstrual, Unscented |
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 | HEB |
CFR Regulation Number | 884.5470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-01-29 |
Decision Date | 1987-02-25 |