The following data is part of a premarket notification filed by Procter & Gamble with the FDA for Always/tampax Bladder Supports.
Device ID | K151413 |
510k Number | K151413 |
Device Name: | Always/Tampax Bladder Supports |
Classification | Pessary, Vaginal |
Applicant | PROCTER & GAMBLE 6110 CENTER HILL AVE. Cincinnati, OH 45224 |
Contact | Lenore Faulhaber |
Correspondent | Lenore Faulhaber PROCTER & GAMBLE 6110 CENTER HILL AVE. Cincinnati, OH 45224 |
Product Code | HHW |
CFR Regulation Number | 884.3575 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-05-27 |
Decision Date | 2015-12-18 |
Summary: | summary |