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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name instrument, cutting, orthopedic
510(k) Number K850527
Device Name ARTHROSCOPY SUCTION BIOPSY PUNCH
Applicant
T. KOROS SURGICAL INSTRUMENTS CORP.
2524 TOWNSGATE RD.
UNIT D
WESTLAKE,  CA  91361
Applicant Contact KOROS
Correspondent
T. KOROS SURGICAL INSTRUMENTS CORP.
2524 TOWNSGATE RD.
UNIT D
WESTLAKE,  CA  91361
Correspondent Contact KOROS
Regulation Number878.4800
Classification Product Code
HTZ  
Date Received02/07/1985
Decision Date 03/14/1985
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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