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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Retractor, Self-Retaining
510(k) Number K993544
Device Name SPACE-OR 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 Number876.4730
Classification Product Code
FFO  
Date Received10/19/1999
Decision Date 12/22/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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