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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plasma, Coagulation Factor Deficient
510(k) Number K912679
Device Name DADE(R) IMMUNOADSORBED FACT V DEF PLASMA (HUMAN)
Applicant
BAXTER HEALTHCARE CORP.
P.O. BOX 520672
MIAMI,  FL  33152
Applicant Contact NANCY A HORNBAKER
Correspondent
BAXTER HEALTHCARE CORP.
P.O. BOX 520672
MIAMI,  FL  33152
Correspondent Contact NANCY A HORNBAKER
Regulation Number864.7290
Classification Product Code
GJT  
Date Received06/18/1991
Decision Date 09/10/1991
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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