FDA 510(k) Application Details - K050013

Device Classification Name	Material, Impression   More FDA Info for this Device
510(K) Number	K050013
Device Name	Material, Impression
Applicant	COLTENE/WHALEDENT AG 1349 LEXINGTON AVENUE NEW YORK, NY 10128 US Other 510(k) Applications for this Company
Contact	HENRY J VOGELSTEIN Other 510(k) Applications for this Contact
Regulation Number	872.3660   More FDA Info for this Regulation Number
Classification Product Code	ELW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/03/2005
Decision Date	02/09/2005
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