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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Binder, Abdominal
510(k) Number K892379
Device Name THE POUCH GROIN & ABDOMINAL STRESS AID
Applicant
Kuhn Industries
2106 98th Ave. S.
Kent,  WA  98031
Applicant Contact EVERETT L KUHN
Correspondent
Kuhn Industries
2106 98th Ave. S.
Kent,  WA  98031
Correspondent Contact EVERETT L KUHN
Regulation Number880.5160
Classification Product Code
FSD  
Date Received04/06/1989
Decision Date 07/20/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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