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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Device Autopheresis-C Plasmapheresis System
Classification Nameseparator, automated, blood cell, diagnostic
Generic Nameautomated blood cell separator -filtration
Regulation Number864.9245
Applicant
Baxter Healthcare Corporation
Round Lake  , IL  60073 
PMA NumberBP850001
Supplement NumberS016
Date Received04/26/1989
Decision Date08/24/1989
Decision Approved
Product Code
GKT[ Registered Establishments with GKT ]
Advisory Committee Hematology
Supplement Type Normal 180 Day Track
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
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