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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fibrin Split Products
510(k) Number K880077
Device Name FIBRINOSTICON
Applicant
ORGANON TEKNIKA CORP.
800 CAPITOLA DR.
DURHAM,  NC  27713
Applicant Contact SHELDON MAZURSKY
Correspondent
ORGANON TEKNIKA CORP.
800 CAPITOLA DR.
DURHAM,  NC  27713
Correspondent Contact SHELDON MAZURSKY
Regulation Number864.7320
Classification Product Code
GHH  
Date Received01/11/1988
Decision Date 02/09/1988
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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