FDA 510(k) Application Details - K111816

Device Classification Name	Bone Grafting Material, Animal Source   More FDA Info for this Device
510(K) Number	K111816
Device Name	Bone Grafting Material, Animal Source
Applicant	LUITPOLD PHARMACEUTICALS, INC. ONE LUITPOLD DR. P.O. BOX 9001 SHIRLEY, NY 11967 US Other 510(k) Applications for this Company
Contact	MARSHA SIMON Other 510(k) Applications for this Contact
Regulation Number	872.3930   More FDA Info for this Regulation Number
Classification Product Code	NPM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/27/2011
Decision Date	09/29/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review