FDA 510(k) Application Details - K240039

Device Classification Name	Tubes, Gastrointestinal (And Accessories)   More FDA Info for this Device
510(K) Number	K240039
Device Name	Tubes, Gastrointestinal (And Accessories)
Applicant	Hangzhou Primecare Medical Co., Ltd. Room 408-409, Zancheng Center West, Shangcheng District Hang zhou 310008 CN Other 510(k) Applications for this Company
Contact	Li Xuedong Other 510(k) Applications for this Contact
Regulation Number	876.5980   More FDA Info for this Regulation Number
Classification Product Code	KNT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/05/2024
Decision Date	04/17/2024
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