FDA 510(k) Application Details - K191231

Device Classification Name	Endoscope Channel Accessory   More FDA Info for this Device
510(K) Number	K191231
Device Name	Endoscope Channel Accessory
Applicant	Smartdata Suzhou Co., Ltd 4F, Block 7, 198#, Jinshan Rd Suzhou 215011 CN Other 510(k) Applications for this Company
Contact	Cindy Ye Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	ODC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/08/2019
Decision Date	06/07/2019
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	Y
Expedited Review