|
Trade Name | Flourish Pediatric Esophageal Atresia Device |
Classification Name | pediatric esophageal atresia anastomosis device |
Generic Name | pediatric esophageal atresia anastomosis device |
Regulation Number | 876.5980 |
Applicant |
WILSON-COOK MEDICAL INC. |
4900 bethania station rd |
winston salem, NC 27105 |
|
HDE Number | H150003 |
Supplement Number | S002 |
Date Received | 10/04/2018 |
Decision Date | 10/25/2018 |
Product Code | |
Advisory Committee |
Gastroenterology |
Supplement Type | special (immediate track) |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for an alternative (single batch verification) load release method following ethylene oxide sterilization. |