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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 K933444
Device Name STAGO FACTOR XI-DEFICIENT PLASMA
Applicant
American Bioproducts Co.
601 N. Jefferson Rd.
Parsippany,  NJ  07054
Applicant Contact ANDREW LOC B. LE
Correspondent
American Bioproducts Co.
601 N. Jefferson Rd.
Parsippany,  NJ  07054
Correspondent Contact ANDREW LOC B. LE
Regulation Number864.7290
Classification Product Code
GJT  
Date Received07/14/1993
Decision Date 10/27/1993
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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