The following data is part of a premarket notification filed by The Procter & Gamble Company with the FDA for Tampax M Plastic Tampons, Unscented.
Device ID | K133244 |
510k Number | K133244 |
Device Name: | TAMPAX M PLASTIC TAMPONS, UNSCENTED |
Classification | Tampon, Menstrual, Unscented |
Applicant | THE PROCTER & GAMBLE COMPANY 6110 CENTER HILL AVENUE Cincinnati, OH 45224 |
Contact | Kathleen Blieszner, Ph.d. |
Correspondent | Kathleen Blieszner, Ph.d. THE PROCTER & GAMBLE COMPANY 6110 CENTER HILL AVENUE Cincinnati, OH 45224 |
Product Code | HEB |
CFR Regulation Number | 884.5470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-10-22 |
Decision Date | 2014-01-09 |
Summary: | summary |