FDA 510(k) Application Details - K011130

Device Classification Name	Denture, Plastic, Teeth   More FDA Info for this Device
510(K) Number	K011130
Device Name	Denture, Plastic, Teeth
Applicant	HERAEUS KULZER, INC. 99 BUSINESS PARK DR. ARMONK, NY 10504 US Other 510(k) Applications for this Company
Contact	RAPHAEL JUDKINS Other 510(k) Applications for this Contact
Regulation Number	872.3590   More FDA Info for this Regulation Number
Classification Product Code	ELM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/13/2001
Decision Date	07/05/2001
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