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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drape, Surgical, Antimicrobial
510(k) Number K010711
Device Name ECOTRACT ADJUSTABLE WOUND PROTECTOR/RETRACTOR
Applicant
Advanced Surgical Concepts (Asc)
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact MARY MCNAMARA-CULLINANE
Correspondent
Advanced Surgical Concepts (Asc)
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact MARY MCNAMARA-CULLINANE
Regulation Number878.4370
Classification Product Code
KKX  
Date Received03/09/2001
Decision Date 05/22/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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