FDA 510(k) Application Details - K210516

Device Classification Name	Stopcock, I.V. Set   More FDA Info for this Device
510(K) Number	K210516
Device Name	Stopcock, I.V. Set
Applicant	Yomura Technologies Inc. No. 8, Gong 8th Rd., Linkou District New Taipei City 24450 TW Other 510(k) Applications for this Company
Contact	David Lee Other 510(k) Applications for this Contact
Regulation Number	880.5440   More FDA Info for this Regulation Number
Classification Product Code	FMG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/23/2021
Decision Date	05/16/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review