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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Qualitative And Quantitative Factor Deficiency
510(k) Number K943225
Device Name COAMATIC FACTOR VIII
Applicant
Pharmacia Hepar, Inc.
160 Industrial Dr.
Franklin,  OH  45005
Applicant Contact CYNTHIA A IPACH
Correspondent
Pharmacia Hepar, Inc.
160 Industrial Dr.
Franklin,  OH  45005
Correspondent Contact CYNTHIA A IPACH
Regulation Number864.7290
Classification Product Code
GGP  
Date Received07/06/1994
Decision Date 11/06/1995
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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