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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 K911996
Device Name SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION
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 Number864.6100
Classification Product Code
JCA  
Date Received04/22/1991
Decision Date 07/17/1991
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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