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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Activated Whole Blood Clotting Time
510(k) Number K923594
Device Name CLOTTRAC COAGULATION CONTROL
Applicant
Medtronic Hemotec, Inc.
7103 S. Revere Pkwy.
Englewood,  CO  80112
Applicant Contact LISA NORRIS
Correspondent
Medtronic Hemotec, Inc.
7103 S. Revere Pkwy.
Englewood,  CO  80112
Correspondent Contact LISA NORRIS
Regulation Number864.7140
Classification Product Code
JBP  
Date Received07/20/1992
Decision Date 09/21/1992
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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