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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 K922031
Device Name HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL
Applicant
Medtronic Hemotec, Inc.
7103 S. Revere Pkwy.
Englewood,  CO  80112
Applicant Contact DESSIE FAFOUTIS
Correspondent
Medtronic Hemotec, Inc.
7103 S. Revere Pkwy.
Englewood,  CO  80112
Correspondent Contact DESSIE FAFOUTIS
Regulation Number864.5680
Classification Product Code
JOX  
Date Received05/01/1992
Decision Date 07/21/1992
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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