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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Multipurpose For In Vitro Coagulation Studies
510(k) Number K894466
Device Name HEPCON(R) CV WHOLE BLOOD COAGULATION CONTROLS
Applicant
Hemotec, Inc.
7103 S. Revere Pkwy.
Englewood,  CO  80112
Applicant Contact BAUGH, PHD
Correspondent
Hemotec, Inc.
7103 S. Revere Pkwy.
Englewood,  CO  80112
Correspondent Contact BAUGH, PHD
Regulation Number864.5425
Classification Product Code
JPA  
Date Received07/18/1989
Decision Date 09/05/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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