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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Control, Plasma, Abnormal
510(k) Number K930959
Device Name FACTOR CONTROL [P]
Applicant
AMERICAN BIOPRODUCTS CO.
601 NORTH JEFFERSON RD.
PARSIPPANY,  NJ  07054
Applicant Contact LOE B LE
Correspondent
AMERICAN BIOPRODUCTS CO.
601 NORTH JEFFERSON RD.
PARSIPPANY,  NJ  07054
Correspondent Contact LOE B LE
Regulation Number864.5425
Classification Product Code
GGC  
Date Received02/24/1993
Decision Date 05/20/1993
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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