FDA 510(k) Application Details - K974772

Device Classification Name	Resin, Denture, Relining, Repairing, Rebasing   More FDA Info for this Device
510(K) Number	K974772
Device Name	Resin, Denture, Relining, Repairing, Rebasing
Applicant	VOCO GMBH 7527 WESTMORELAND AVE. ST. LOUIS, MO 63105 US Other 510(k) Applications for this Company
Contact	EVAN DICK 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	12/22/1997
Decision Date	02/10/1998
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