The following data is part of a premarket notification filed by Personal Products Co. with the FDA for Unscented Menstrual Tampon W/a Modified Applicator.
Device ID | K912552 |
510k Number | K912552 |
Device Name: | UNSCENTED MENSTRUAL TAMPON W/A MODIFIED APPLICATOR |
Classification | Tampon, Menstrual, Unscented |
Applicant | PERSONAL PRODUCTS CO. Milltown, NJ 08850 |
Contact | Petrone |
Correspondent | Petrone PERSONAL PRODUCTS CO. Milltown, NJ 08850 |
Product Code | HEB |
CFR Regulation Number | 884.5470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-06-11 |
Decision Date | 1991-09-24 |