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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Protamine Sulphate
510(k) Number K910105
Device Name PROTAMINE RESPONSE TEST CATALOGUE NUMBER PRT 200
Applicant
International Technidyne Corp.
23 Nevsky St.
Edison,  NJ  08820
Applicant Contact LES HEIMANN
Correspondent
International Technidyne Corp.
23 Nevsky St.
Edison,  NJ  08820
Correspondent Contact LES HEIMANN
Regulation Number864.7525
Classification Product Code
GFT  
Date Received01/03/1991
Decision Date 02/26/1991
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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