FDA 510(k) Application Details - K964692

Device Classification Name	Material, Impression   More FDA Info for this Device
510(K) Number	K964692
Device Name	Material, Impression
Applicant	J. MORITA USA, INC. 601 13TH STREET, N.W. SUITE 500 NORTH WASHINGTON, DC 20005 US Other 510(k) Applications for this Company
Contact	TERRY G MAHN 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	11/22/1996
Decision Date	02/25/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review