FDA 510(k) Application Details - K063151

Device Classification Name	Injector, Pen   More FDA Info for this Device
510(K) Number	K063151
Device Name	Injector, Pen
Applicant	ELI LILLY AND CO. LILLY CORPORATE CENTER INDIANAPOLIS, IN 46285 US Other 510(k) Applications for this Company
Contact	LEEANN CHAMBERS Other 510(k) Applications for this Contact
Regulation Number	880.5860   More FDA Info for this Regulation Number
Classification Product Code	NSC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/16/2006
Decision Date	01/09/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review