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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 K955843
Device Name TAS PTONE
Applicant
Cardiovascular Diagnostic Services
5301 Departure Dr.
Raleigh,  NC  27604
Applicant Contact CYNTHIA PRITCHARD, PH.D.
Correspondent
Cardiovascular Diagnostic Services
5301 Departure Dr.
Raleigh,  NC  27604
Correspondent Contact CYNTHIA PRITCHARD, PH.D.
Regulation Number864.7750
Classification Product Code
GJS  
Subsequent Product Code
JPA  
Date Received12/26/1995
Decision Date 03/18/1996
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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