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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 Nameapplicator, hyperthermia, interstitial
Generic Nameinterstitial hyperthermia system
ApplicantCOOK, INC.
PMA NumberP880078
Date Received10/31/1988
Decision Date10/17/1989
Withdrawal Date 06/30/2009
Product Code
LMZ[ Registered Establishments with LMZ ]
Docket Number 89M-0461
Notice Date 11/17/1989
Advisory Committee Radiology
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S004 S005 S006 S007 S008 S009 S010