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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound And Burn, Occlusive
510(k) Number K943111
Device Name TRANSPARENT DRESSING
Applicant
Acutek Adhesive Specialties, Inc.
540 N. Oak St.
Inglewood,  CA  90302
Applicant Contact GREG HOLLAND
Correspondent
Acutek Adhesive Specialties, Inc.
540 N. Oak St.
Inglewood,  CA  90302
Correspondent Contact GREG HOLLAND
Classification Product Code
MGP  
Date Received06/27/1994
Decision Date 09/12/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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