The following data is part of a premarket notification filed by Procter & Gamble Co. with the FDA for Tampax Satin Tampons, Closed End Flushable Applicator; Tampax Tampons, Open End Flushable Applicator.
Device ID | K002096 |
510k Number | K002096 |
Device Name: | TAMPAX SATIN TAMPONS, CLOSED END FLUSHABLE APPLICATOR; TAMPAX TAMPONS, OPEN END FLUSHABLE APPLICATOR |
Classification | Tampon, Menstrual, Unscented |
Applicant | PROCTER & GAMBLE CO. 6100 CENTER HILL AVE. Cincinnati, OH 45224 |
Contact | Mark M Anderson |
Correspondent | Mark M Anderson PROCTER & GAMBLE CO. 6100 CENTER HILL AVE. Cincinnati, OH 45224 |
Product Code | HEB |
CFR Regulation Number | 884.5470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-07-11 |
Decision Date | 2000-09-08 |