FDA 510(k) Application Details - K142414

Device Classification Name	Syringe, Cartridge   More FDA Info for this Device
510(K) Number	K142414
Device Name	Syringe, Cartridge
Applicant	INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. PLAINSBORO, NJ 08536 US Other 510(k) Applications for this Company
Contact	Judith E. O'Grady 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	08/28/2014
Decision Date	10/30/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review