FDA 510(k) Application Details - K964323

Device Classification Name	Material, Impression   More FDA Info for this Device
510(K) Number	K964323
Device Name	Material, Impression
Applicant	FEN DENTAL MFG., INC. 1819 SOUTH MAY STREET, 2F CHICCAGO, IL 60608 US Other 510(k) Applications for this Company
Contact	ROBERT W BAUER, PH.D. 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	10/30/1996
Decision Date	12/16/1996
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