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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name instrument, coagulation, automated
510(k) Number K951072
Device Name PROTIME MICROCOAGULATION SYSTEM
Applicant
INTERNATIONAL TECHNIDYNE CORP.
23 NEVSKY ST.
EDISON,  NJ  08820
Applicant Contact ROBERT N BORGHESE
Correspondent
INTERNATIONAL TECHNIDYNE CORP.
23 NEVSKY ST.
EDISON,  NJ  08820
Correspondent Contact ROBERT N BORGHESE
Regulation Number864.5400
Classification Product Code
GKP  
Subsequent Product Code
GJS  
Date Received03/08/1995
Decision Date 10/27/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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