FDA 510(k) Application Details - K191531

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K191531
Device Name	Syringe, Piston
Applicant	Shina Med Corporation 455-30 Bogaewonsam-ro, Bogae-myun Anseong-si 456-871 KR Other 510(k) Applications for this Company
Contact	Park Sung-soon Other 510(k) Applications for this Contact
Regulation Number	880.5860   More FDA Info for this Regulation Number
Classification Product Code	FMF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/10/2019
Decision Date	09/06/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review