FDA 510(k) Application Details - K151630

Device Classification Name	More FDA Info for this Device
510(K) Number	K151630
Device Name	G.o.c.c.l.e.s.
Applicant	PIERREL PHARMA S.R.L. STRADA STATALE APPIA 46/48 CAPUA 81043 IT Other 510(k) Applications for this Company
Contact	FABIO VELOTTI Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	NXV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/17/2015
Decision Date	09/15/2015
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