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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCURESIS PLASMA SEPARATOR
Classification Nameseparator for therapeutic purposes, membrane automated blood cell/plasma
Generic Nameseparator for therapeutic purposes, membrane automated blood cell/plasma
Applicant
ORGANON TEKNIKA CORP.
5300 south portland ave.
oklahoma city, OK 73119
PMA NumberP830010
Supplement NumberS001
Date Received11/19/1984
Decision Date02/12/1985
Product Code
MDP[ Registered Establishments with MDP ]
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination Product No
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