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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Surgical
510(k) Number K002755
Device Name NON-ABSORBING STERNATOMY MONOFILAMENT SUTURE
Applicant
T. Korossurgical Instruments Corp.
610 Flinn Ave.
Moorepark,  CA  93021
Applicant Contact TIBOR KOROS
Correspondent
T. Korossurgical Instruments Corp.
610 Flinn Ave.
Moorepark,  CA  93021
Correspondent Contact TIBOR KOROS
Regulation Number888.3030
Classification Product Code
LRN  
Date Received09/05/2000
Decision Date 12/04/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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