The following data is part of a premarket notification filed by Personal Products Co. with the FDA for Stayfree(tm) Maxi-pad.
Device ID | K913747 |
510k Number | K913747 |
Device Name: | STAYFREE(TM) MAXI-PAD |
Classification | Pad, Menstrual, Unscented |
Applicant | PERSONAL PRODUCTS CO. Milltown, NJ 08850 |
Contact | Ruber |
Correspondent | 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 | 1991-08-21 |
Decision Date | 1991-11-05 |