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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, For Neurosurgery
510(k) Number K881160
Device Name CRANK FRAME RETRACTOR
Applicant
T. KOROS SURGICAL INSTRUMENTS CORP.
610 FLINN AVE.
MOORPARK,  CA  93021
Applicant Contact TIBOR KOROS
Correspondent
T. KOROS SURGICAL INSTRUMENTS CORP.
610 FLINN AVE.
MOORPARK,  CA  93021
Correspondent Contact TIBOR KOROS
Regulation Number882.4800
Classification Product Code
GZT  
Date Received03/18/1988
Decision Date 04/06/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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