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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Garment, Protective, For Incontinence
510(k) Number K854408
Device Name ADULT ABSORBENT INCONTINENT BRIEF
Applicant
Weyerhaeuser Co.
Tacoma,  WA  98477
Applicant Contact HOWLAND
Correspondent
Weyerhaeuser Co.
Tacoma,  WA  98477
Correspondent Contact HOWLAND
Regulation Number876.5920
Classification Product Code
EYQ  
Date Received11/01/1985
Decision Date 11/19/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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