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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Coagulation
510(k) Number K021976
Device Name FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON
Applicant
Vital Scientific N.V.
One Gateway Center
Suite 411
Newton,  MA  02458
Applicant Contact ISRAEL M STEIN
Correspondent
Vital Scientific N.V.
One Gateway Center
Suite 411
Newton,  MA  02458
Correspondent Contact ISRAEL M STEIN
Regulation Number864.5400
Classification Product Code
KQG  
Subsequent Product Code
JBT  
Date Received06/17/2002
Decision Date 10/25/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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