The following data is part of a premarket notification filed by Procter & Gamble Mfg. Co. with the FDA for Rely Tampon.
Device ID | K791274 |
510k Number | K791274 |
Device Name: | RELY TAMPON |
Classification | Tampon, Menstrual, Unscented |
Applicant | PROCTER & GAMBLE MFG. CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HEB |
CFR Regulation Number | 884.5470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-07-09 |
Decision Date | 1979-08-03 |