FDA 510(k) Application Details - K103084

Device Classification Name	Screw, Fixation, Intraosseous   More FDA Info for this Device
510(K) Number	K103084
Device Name	Screw, Fixation, Intraosseous
Applicant	JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S 11234 EL CAMINO REAL SUITE 200 SAN DIEGO, CA 92130 US Other 510(k) Applications for this Company
Contact	DAVID J COLLETTE Other 510(k) Applications for this Contact
Regulation Number	872.4880   More FDA Info for this Regulation Number
Classification Product Code	DZL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/19/2010
Decision Date	02/14/2011
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