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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Protamine Sulphate
510(k) Number K944115
Device Name HEPARIN ASSAY CARTRIDGES AND CONTROLS
Applicant
Medtronic Hemotec, Inc.
7103 S. Revere Pkwy.
Englewood,  CO  80112
Applicant Contact ROBERT F BAUGH
Correspondent
Medtronic Hemotec, Inc.
7103 S. Revere Pkwy.
Englewood,  CO  80112
Correspondent Contact ROBERT F BAUGH
Regulation Number864.7525
Classification Product Code
GFT  
Date Received08/23/1994
Decision Date 03/24/1995
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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