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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
510(k) Number K850789
Device Name FLUTED SUCTION MENISCAL CUTTER
Applicant
T. Korossurgical Instruments Corp.
2524 Townsgate Rd.
Unit D
Westlake,  CA  91361
Applicant Contact TIBOR B KOROS
Correspondent
T. Korossurgical Instruments Corp.
2524 Townsgate Rd.
Unit D
Westlake,  CA  91361
Correspondent Contact TIBOR B KOROS
Regulation Number878.4820
Classification Product Code
KIJ  
Date Received02/26/1985
Decision Date 06/28/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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