The following data is part of a premarket notification filed by Personal Products Co. with the FDA for Sure & Natural Maxishields W/superabsorbent.
Device ID | K844342 |
510k Number | K844342 |
Device Name: | SURE & NATURAL MAXISHIELDS W/SUPERABSORBENT |
Classification | Pad, Menstrual, Unscented |
Applicant | PERSONAL PRODUCTS CO. Milltown, NJ 08850 |
Contact | Caparotta |
Correspondent | Caparotta 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 | 1984-11-08 |
Decision Date | 1985-01-10 |