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FDA 510(k) Application Details - K223683
Device Classification Name
More FDA Info for this Device
510(K) Number
K223683
Device Name
EnteraLoc Flow
Applicant
Vonco Products
10826 250th Avenue
Trevor, WI 53179 US
Other 510(k) Applications for this Company
Contact
Christie Marr
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
12/08/2022
Decision Date
07/10/2023
Decision
SESE - SUBST EQUIV
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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