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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table And Attachments, Operating-Room
510(k) Number K875291
Device Name SPINAL SURGERY FRAME
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 Number878.4950
Classification Product Code
BWN  
Date Received12/30/1987
Decision Date 01/22/1988
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
Predetermined Change
Control Plan Authorized		 No
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