FDA 510(k) Application Details - K201789

Device Classification Name	Media, Culture, Ex Vivo, Tissue And Cell   More FDA Info for this Device
510(K) Number	K201789
Device Name	Media, Culture, Ex Vivo, Tissue And Cell
Applicant	Energy Delivery Solutions 3315 Industrial Parkway Jeffersonville, IN 47130 US Other 510(k) Applications for this Company
Contact	William Ehringer Other 510(k) Applications for this Contact
Regulation Number	876.5885   More FDA Info for this Regulation Number
Classification Product Code	NDS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/30/2020
Decision Date	09/20/2021
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