FDA 510(k) Application Details - K181522

Device Classification Name	Duodenoscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K181522
Device Name	Duodenoscope And Accessories, Flexible/Rigid
Applicant	PENTAX of America, Inc. 3 Paragon Drive Montvale, NJ 07645-1782 US Other 510(k) Applications for this Company
Contact	William Goeller Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FDT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/11/2018
Decision Date	07/09/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review