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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Time, Prothrombin
510(k) Number K972866
Device Name HEMOCHRON JR. MIOCROCOAGULATION CITRATED PT
Applicant
International Technidyne Corp.
8 Olsen Ave.
Edison,  NJ  08820
Applicant Contact ROBERT H MATLAND
Correspondent
International Technidyne Corp.
8 Olsen Ave.
Edison,  NJ  08820
Correspondent Contact ROBERT H MATLAND
Regulation Number864.7750
Classification Product Code
GJS  
Date Received08/04/1997
Decision Date 09/30/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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