FDA 510(k) Application Details - K993017

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K993017
Device Name	Syringe, Piston
Applicant	SHIN CHANG MEDICAL CO., LTD. 3762 SOUTH 150 EAST SALT LAKE CITY, UT 84115 US Other 510(k) Applications for this Company
Contact	JAN J FRANK 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	09/08/1999
Decision Date	02/25/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review