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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceVOL. HYPERTHERMIA TREATMENT SYSTEM MODEL VH8500
Classification Nameapplicator, hyperthermia, interstitial
Generic Nameapplicator, hyperthermia, interstitial
Applicant
COOK, INC.
p.o. box 489
bloomington, IN 47402
PMA NumberP880078
Supplement NumberS005
Date Received09/19/1990
Decision Date10/28/1991
Product Code
LMZ[ Registered Establishments with LMZ ]
Advisory Committee Radiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
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