FDA 510(k) Application Details - K972285

Device Classification Name	Syringe, Cartridge   More FDA Info for this Device
510(K) Number	K972285
Device Name	Syringe, Cartridge
Applicant	GETTIG PHARMACEUTICAL INSTRUMENT CO. 1 STREAM SIDE PL. WEST SPRING MILLS, PA 16875-0085 US Other 510(k) Applications for this Company
Contact	KEVIN FEE Other 510(k) Applications for this Contact
Regulation Number	872.6770   More FDA Info for this Regulation Number
Classification Product Code	EJI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/19/1997
Decision Date	09/11/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review