FDA 510(k) Application Details - K163424

Device Classification Name	Pump, Air, Non-Manual, For Endoscope   More FDA Info for this Device
510(K) Number	K163424
Device Name	Pump, Air, Non-Manual, For Endoscope
Applicant	United State Endoscopy Group, Inc. 5976 Heisley Rd. Mentor, OH 44060 US Other 510(k) Applications for this Company
Contact	Ganga Kolli Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FEQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/06/2016
Decision Date	01/04/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review