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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Bleeding Time
510(k) Number K911745
Device Name SIMPLATE PEDIATRIC
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 Number864.6100
Classification Product Code
JCA  
Date Received04/18/1991
Decision Date 08/09/1991
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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