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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tape And Bandage, Adhesive
510(k) Number K842946
Device Name ACU-PATCH
Applicant
Acutek
540 N. Oak St.
Inglewood,  CA  90302
Applicant Contact KAREN A NERI
Correspondent
Acutek
540 N. Oak St.
Inglewood,  CA  90302
Correspondent Contact KAREN A NERI
Regulation Number880.5240
Classification Product Code
KGX  
Date Received07/26/1984
Decision Date 12/07/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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