FDA 510(k) Application Details - K983558

Device Classification Name	Clasp, Preformed   More FDA Info for this Device
510(K) Number	K983558
Device Name	Clasp, Preformed
Applicant	DENTAMAX, INC. 4311 S.W. RESEARCH WAY CORVALLIS, OR 97333 US Other 510(k) Applications for this Company
Contact	MARTIN A RIGUTTO Other 510(k) Applications for this Contact
Regulation Number	872.3285   More FDA Info for this Regulation Number
Classification Product Code	EHP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/13/1998
Decision Date	01/07/1999
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