FDA 510(k) Application Details - K974231

Device Classification Name	Material, Impression   More FDA Info for this Device
510(K) Number	K974231
Device Name	Material, Impression
Applicant	ESPE GMBH & CO. KG. AM GRIESBERG 2 SEEFELD D-82229 DE Other 510(k) Applications for this Company
Contact	BARBARA WAGNER-SCHUH 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	11/12/1997
Decision Date	01/29/1998
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