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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Osteotome, Manual
510(k) Number K920001
Device Name HEMOLAB SILIMAT REAGENT
Applicant
Biomerieux Vitek, Inc.
595 Anglum Dr.
Hazelwood,  MO  63042
Applicant Contact DAVID K.BROADWAY
Correspondent
Biomerieux Vitek, Inc.
595 Anglum Dr.
Hazelwood,  MO  63042
Correspondent Contact DAVID K.BROADWAY
Regulation Number878.4800
Classification Product Code
GFI  
Date Received01/02/1992
Decision Date 09/25/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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