The following data is part of a premarket notification filed by Personal Products Co. with the FDA for Menstrual Tampon.
Device ID | K897008 |
510k Number | K897008 |
Device Name: | MENSTRUAL TAMPON |
Classification | Tampon, Menstrual, Unscented |
Applicant | PERSONAL PRODUCTS CO. Milltown, NJ 08850 |
Contact | A. J Huetteman |
Correspondent | A. J Huetteman 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 | 1989-12-20 |
Decision Date | 1990-01-08 |