The following data is part of a premarket notification filed by Weyerhaeuser Co. with the FDA for Absorbent Incontinent Pads & Briefs.
Device ID | K834359 |
510k Number | K834359 |
Device Name: | ABSORBENT INCONTINENT PADS & BRIEFS |
Classification | Garment, Protective, For Incontinence |
Applicant | WEYERHAEUSER CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | EYQ |
CFR Regulation Number | 876.5920 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-12-13 |
Decision Date | 1984-03-05 |