The following data is part of a premarket notification filed by Personal Products Co. with the FDA for Sure & Natural Maxishields.
Device ID | K823239 |
510k Number | K823239 |
Device Name: | SURE & NATURAL MAXISHIELDS |
Classification | Pad, Menstrual, Unscented |
Applicant | PERSONAL PRODUCTS CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | HHD |
CFR Regulation Number | 884.5435 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-11-01 |
Decision Date | 1982-12-16 |