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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Motor, Surgical Instrument, Pneumatic Powered
510(k) Number K872951
Device Name AMERICAN BRAIN RETRACTOR COVER
Applicant
American Silk Sutures, Inc.
57 Munroe St.
Lynn,  MA  01901
Applicant Contact ED GREENSPAN
Correspondent
American Silk Sutures, Inc.
57 Munroe St.
Lynn,  MA  01901
Correspondent Contact ED GREENSPAN
Regulation Number878.4820
Classification Product Code
GET  
Date Received07/28/1987
Decision Date 09/16/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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