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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 NameHARRISON FETAL BLADDER STENT SET
Classification Namestent, bladder, fetal
Generic Namestent, bladder, fetal
Applicant
Cook Incorporated
750 daniels way
p.o. box 489
bloomington, IN 47402
HDE NumberH960001
Supplement NumberS003
Date Received11/01/2012
Decision Date02/22/2013
Product Code
MPR[ Registered Establishments with MPR ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 75 day track
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval to change the raw material of one of the components of the harrison fetal bladder stent set.
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