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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 K952608
Device Name MDA SIMPLASTIN LS
Applicant
Organon Teknika Corp.
100 Akzo Ave.
Durham,  NC  27712
Applicant Contact ANN M QUINN
Correspondent
Organon Teknika Corp.
100 Akzo Ave.
Durham,  NC  27712
Correspondent Contact ANN M QUINN
Regulation Number864.7750
Classification Product Code
GJS  
Date Received06/07/1995
Decision Date 10/06/1995
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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