FDA 510(k) Application Details - K043301

Device Classification Name	Dam, Rubber   More FDA Info for this Device
510(K) Number	K043301
Device Name	Dam, Rubber
Applicant	GC AMERICA, INC. 3737 WEST 127TH ST. ALSIP, IL 60803 US Other 510(k) Applications for this Company
Contact	TERRY JORITZ Other 510(k) Applications for this Contact
Regulation Number	872.6300   More FDA Info for this Regulation Number
Classification Product Code	EIE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/30/2004
Decision Date	01/25/2005
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