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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 K881157
Device Name STERNUM SPREADER AND MITRAL VALVE 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 Number878.4800
Classification Product Code
GAD  
Date Received03/18/1988
Decision Date 04/06/1988
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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