FDA 510(k) Application Details - K181887

Device Classification Name	Anti Fog Solution And Accessories, Endoscopy   More FDA Info for this Device
510(K) Number	K181887
Device Name	Anti Fog Solution And Accessories, Endoscopy
Applicant	Advanced Medical Design Co., Ltd 4-5F, No 29, Wuquan 5th Rd., Wugu Dist. New Taipei City 24888 TW Other 510(k) Applications for this Company
Contact	Silvia Yeh Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	OCT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/13/2018
Decision Date	01/22/2019
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	N
Expedited Review