The following data is part of a premarket notification filed by Personal Products Co. with the FDA for Carefree(tm) Festiva Pantyshields.
Device ID | K901664 |
510k Number | K901664 |
Device Name: | CAREFREE(TM) FESTIVA PANTYSHIELDS |
Classification | Pad, Menstrual, Unscented |
Applicant | PERSONAL PRODUCTS CO. Milltown, NJ 08850 |
Contact | L. J Ruber |
Correspondent | L. J Ruber PERSONAL PRODUCTS CO. Milltown, NJ 08850 |
Product Code | HHD |
CFR Regulation Number | 884.5435 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-04-10 |
Decision Date | 1990-06-22 |