The following data is part of a premarket notification filed by Personal Products Co. with the FDA for Sure & Natural(tm) Unscented Menstrual Pad.
Device ID | K895519 |
510k Number | K895519 |
Device Name: | SURE & NATURAL(TM) UNSCENTED MENSTRUAL PAD |
Classification | Pad, Menstrual, Unscented |
Applicant | PERSONAL PRODUCTS CO. Milltown, NJ 08850 |
Contact | R. A Petrone |
Correspondent | R. A Petrone 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 | 1989-09-12 |
Decision Date | 1989-11-29 |