FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON

Instrument, Coagulation

VITAL SCIENTIFIC N.V.

The following data is part of a premarket notification filed by Vital Scientific N.v. with the FDA for Fibron-1, Fibron-4, Quikcoag, Fibron.

Pre-market Notification Details

Device IDK021976
510k NumberK021976
Device Name:FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON
ClassificationInstrument, Coagulation
Applicant VITAL SCIENTIFIC N.V. ONE GATEWAY CENTER SUITE 411 Newton,  MA  02458
ContactIsrael M Stein
CorrespondentIsrael M Stein
VITAL SCIENTIFIC N.V. ONE GATEWAY CENTER SUITE 411 Newton,  MA  02458
Product CodeKQG  
CFR Regulation Number864.5400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-06-17
Decision Date2002-10-25
Summary:summary

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