FDA 510(k) Application Details - K961995

Device Classification Name	Resin, Denture, Relining, Repairing, Rebasing   More FDA Info for this Device
510(K) Number	K961995
Device Name	Resin, Denture, Relining, Repairing, Rebasing
Applicant	HERAEUS KULZER, INC. 10005 MUIRLANDS BLVD. IRVINE, CA 92718-2595 US Other 510(k) Applications for this Company
Contact	SHARON PARKER Other 510(k) Applications for this Contact
Regulation Number	872.3760   More FDA Info for this Regulation Number
Classification Product Code	EBI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/21/1996
Decision Date	06/26/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review