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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DevicePLASMAFLO OP-05 W(A) ASAHI PLASMA SEPARATOR
Classification Nameseparator for therapeutic purposes, membrane automated blood cell/plasma
Generic Nameseparator for therapeutic purposes, membrane automated blood cell/plasma
Applicant
Asahi Kasei Medical Co., Ltd.
1-105 kanda jinbocho
chiyoda-ku
tokyo 101-8-8101
PMA NumberP820033
Date Received05/26/1982
Decision Date07/05/1983
Product Code
MDP[ Registered Establishments with MDP ]
Docket Number 83M-0236
Notice Date 08/12/1983
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination Product No
Supplements: S001 S005 S006 S007 S008 S009 S010 
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