FDA 510(k) Application Details - K202838

Device Classification Name	Endoscopic Storage Cover   More FDA Info for this Device
510(K) Number	K202838
Device Name	Endoscopic Storage Cover
Applicant	GA Health Company Limited Unit 18, 21/F, Metropole Square, 2 On Yiu Street, Shatin Hong Kong 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	OCU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/25/2020
Decision Date	03/05/2021
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