FDA 510(k) Application Details - K041398

Device Classification Name	Material, Impression   More FDA Info for this Device
510(K) Number	K041398
Device Name	Material, Impression
Applicant	GC AMERICA, INC. 3737 W. 127TH ST. ALSIP, IL 60803 US Other 510(k) Applications for this Company
Contact	TERRY L JORITZ 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	05/26/2004
Decision Date	06/25/2004
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