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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 K974891
Device Name ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197013
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 Received12/30/1997
Decision Date 10/21/1998
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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