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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Heparin, Automated
510(k) Number K911240
Device Name HEPCON HMS WITH BODY SURFACE AREA CALCULATION
Applicant
Hemotech, Inc.
7103 S. Revere Pkwy.
Englewood,  CO  80112
Applicant Contact ROBERT F BAUGH
Correspondent
Hemotech, Inc.
7103 S. Revere Pkwy.
Englewood,  CO  80112
Correspondent Contact ROBERT F BAUGH
Regulation Number864.5680
Classification Product Code
JOX  
Date Received03/21/1991
Decision Date 07/17/1991
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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