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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameCURESIS PLASMA SEPARATOR
Classification Nameseparator, automated, blood cell and plasma, therapeutic
Generic Nameplasma separator
ApplicantORGANON TEKNIKA CORP.
PMA NumberP830010
Date Received03/02/1983
Decision Date09/19/1984
Product Code
LKN[ Registered Establishments with LKN ]
Docket Number 84M-0338
Notice Date 11/09/1984
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination Product No
Supplements: S001 S003 
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