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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Retractor
510(k) Number K812389
Device Name SURGICAL LOOPS
Applicant
BERKELEY MEDEVICES
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
BERKELEY MEDEVICES
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4800
Classification Product Code
GAD  
Date Received08/20/1981
Decision Date 11/16/1981
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
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