HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS.

Analyzer, Heparin, Automated

HEMOTEC, INC.

The following data is part of a premarket notification filed by Hemotec, Inc. with the FDA for Hemotec Hepcon Hms Coagulation System & Access..

Pre-market Notification Details

Device IDK894317
510k NumberK894317
Device Name:HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS.
ClassificationAnalyzer, Heparin, Automated
Applicant HEMOTEC, INC. 7103 SOUTH REVERE PKWY. Englewood,  CO  80112
ContactTaylor, M.s.
CorrespondentTaylor, M.s.
HEMOTEC, INC. 7103 SOUTH REVERE PKWY. Englewood,  CO  80112
Product CodeJOX  
CFR Regulation Number864.5680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-07-14
Decision Date1989-09-05

NIH GUDID Devices

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