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FDA 510(k) Application Details - K191784
Device Classification Name
More FDA Info for this Device
510(K) Number
K191784
Device Name
Gabriel Feeding Tube with Balloon, and EnFit Connector
Applicant
Syncro Medical Innovations, Inc.
515 Mulberry St Suite 200
Macon, GA 31201-6308 US
Other 510(k) Applications for this Company
Contact
Sabry Gabriel
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PIF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/03/2019
Decision Date
11/15/2019
Decision
SEKD - SUBST EQUIV - KIT WITH DRUGS
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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