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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 Control
510(k) Number K962674
Device Name STA - VWF CONTROL [N]+[P] KIT
Applicant
American Bioproducts Co.
5 Century Dr.
Parisppany,  NJ  07054
Applicant Contact ANDREW LOC B. LE
Correspondent
American Bioproducts Co.
5 Century Dr.
Parisppany,  NJ  07054
Correspondent Contact ANDREW LOC B. LE
Regulation Number864.5425
Classification Product Code
GGN  
Date Received07/09/1996
Decision Date 07/23/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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