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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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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 HDE to get an up-to-date view of this device.
 
Trade NameURO-STIM THERAPEUTIC STIMULATION UNIT
Classification Namestimulator, bladder
Generic Namestimulator, bladder
Applicant
WILLIAM E. KAPLAN, M.D.
2300 children's plaza, #24
chicago, IL 60614
HDE NumberH970003
Supplement NumberS001
Date Received03/12/1999
Decision Date04/08/1999
Product Code
NAZ
Advisory Committee Gastroenterology
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the purchase of 5 stimulators and 100 size #8 electrocatheters.
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