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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Aspiration And Injection, Reusable
510(k) Number K880812
Device Name SPINAL NEEDLE
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 Number878.4800
Classification Product Code
GDM  
Date Received02/26/1988
Decision Date 03/11/1988
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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