FDA 510(k) Application Details - K991888

Device Classification Name	Syringe, Cartridge   More FDA Info for this Device
510(K) Number	K991888
Device Name	Syringe, Cartridge
Applicant	SPARTAN ULTRASONICS, INC. 1663 FENTON BUSINESS PARK CT. FENTON, MO 63026 US Other 510(k) Applications for this Company
Contact	ALDO EAGLE 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	06/02/1999
Decision Date	08/25/1999
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