FDA 510(k) Application Details - K980968

Device Classification Name	Material, Impression   More FDA Info for this Device
510(K) Number	K980968
Device Name	Material, Impression
Applicant	LONE STAR TECHNOLOGIES 31 RUNNYMEADE CHATHAM, NJ 07928 US Other 510(k) Applications for this Company
Contact	EDWARD SPEHAR 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	03/16/1998
Decision Date	06/09/1998
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