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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 NameCOBE CENTRY(R) TPE SYSTEM
Classification Nameseparator, automated, blood cell and plasma, therapeutic
Generic Nametherapeutic plasma exchange unit
ApplicantGAMBRO BCT, INC.
PMA NumberP810023
Date Received05/18/1981
Decision Date03/16/1982
Withdrawal Date 10/09/2007
Product Code
LKN[ Registered Establishments with LKN ]
Notice Date 04/09/1982
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination Product No
Supplements: S002 
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