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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Multipurpose For In Vitro Coagulation Studies
510(k) Number K930068
Device Name HEMOCHRON MODEL 8000/FACTOR VI PREMIER COAGULATION
Applicant
Technidyne Corp.
23 Nevsky St.
Edison,  NJ  08820
Applicant Contact MATT LESNIESKI
Correspondent
Technidyne Corp.
23 Nevsky St.
Edison,  NJ  08820
Correspondent Contact MATT LESNIESKI
Regulation Number864.5425
Classification Product Code
JPA  
Date Received01/06/1993
Decision Date 09/02/1993
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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