FDA 510(k) Application Details - K974894

Device Classification Name	Material, Impression   More FDA Info for this Device
510(K) Number	K974894
Device Name	Material, Impression
Applicant	MATECH, INC. 13010 SAN FERNANDO RD. SYLMAR, CA 91342 US Other 510(k) Applications for this Company
Contact	PAUL L SAXTON 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	12/31/1997
Decision Date	02/12/1998
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