FDA 510(k) Application Details - K971664

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K971664
Device Name	Syringe, Piston
Applicant	ALSHIFA MEDICAL SYRINGES MFG. CO., LTD. 55 NORTHERN BLVD., SUITE 410 GREAT NECK, NY 11021 US Other 510(k) Applications for this Company
Contact	MILTON N BENEKE 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	05/06/1997
Decision Date	07/25/1997
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