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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 K853198
Device Name ADDITIONAL HEMOTEC ACT COAGULATION CARTRIDGES
Applicant
Medical Device Consultants, Inc.
45 W. St.
Suite 2
North Attleboro,  MA  02703
Applicant Contact WILLIAM A MORTON
Correspondent
Medical Device Consultants, Inc.
45 W. St.
Suite 2
North Attleboro,  MA  02703
Correspondent Contact WILLIAM A MORTON
Regulation Number864.5425
Classification Product Code
JPA  
Date Received07/30/1985
Decision Date 10/04/1985
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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