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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.
Classification Nameceramics, calcium triphosphate/hydroxypatite, non-load bearing uses
Generic Nameplasma separator system
ApplicantFENWAL, INC.
PMA NumberP820032
Date Received05/25/1982
Decision Date10/07/1983
Withdrawal Date 07/10/2014
Product Code
LMN[ Registered Establishments with LMN ]
Docket Number 83M-0352
Notice Date 11/03/1983
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005