FDA 510(k) Application Details - K193422

Device Classification Name	Needle, Hypodermic, Single Lumen   More FDA Info for this Device
510(K) Number	K193422
Device Name	Needle, Hypodermic, Single Lumen
Applicant	Sandstone Medical (Suzhou) Inc. A601, Guangzhou International Business Incubator, Guangzhou Science Park Suzhou 215301 CN Other 510(k) Applications for this Company
Contact	Juanjuan Sun Other 510(k) Applications for this Contact
Regulation Number	880.5570   More FDA Info for this Regulation Number
Classification Product Code	FMI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/09/2019
Decision Date	02/02/2021
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