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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 NameFlourish Pediatric Atresia Esophageal Atresia Device
Classification Namepediatric esophageal atresia anastomosis device
Generic Namepediatric esophageal atresia anastomosis device
Regulation Number876.5980
Applicant
Wilson-Cook Medical, Inc.
4900 bethania station rd.
winston-salem, NC 27105
HDE NumberH150003
Supplement NumberS001
Date Received06/16/2017
Decision Date04/27/2018
Product Code
PTK
Advisory Committee Gastroenterology
Supplement Typenormal 75 day track
Supplement Reason postapproval study protocol - osb
Expedited Review Granted? No
Combination ProductNo
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