The following data is part of a premarket notification filed by Weyerhaeuser Co. with the FDA for Adult Absorbent Incontinent Brief.
Device ID | K854408 |
510k Number | K854408 |
Device Name: | ADULT ABSORBENT INCONTINENT BRIEF |
Classification | Garment, Protective, For Incontinence |
Applicant | WEYERHAEUSER CO. Tacoma, WA 98477 |
Contact | Howland |
Correspondent | Howland WEYERHAEUSER CO. Tacoma, WA 98477 |
Product Code | EYQ |
CFR Regulation Number | 876.5920 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-11-01 |
Decision Date | 1985-11-19 |