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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.
 
Trade NamePLASMA SEPARATION SYSTEM
Classification Nameseparator, automated, blood cell and plasma, therapeutic
Generic Nameautomated blood cell and plasma separator for ther
ApplicantFENWAL, INC.
PMA NumberP820032
Supplement NumberS005
Date Received07/07/1987
Decision Date08/25/1987
Product Code
LKN[ Registered Establishments with LKN ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason other
Expedited Review Granted? No
Combination Product No
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