FDA 510(k) Application Details - K990667

Device Classification Name	Prosthesis, Condyle, Mandibular, Temporary   More FDA Info for this Device
510(K) Number	K990667
Device Name	Prosthesis, Condyle, Mandibular, Temporary
Applicant	KLS-MARTIN L.P. 3234 ELLA LN. NEW PORT RICHEY, FL 34655 US Other 510(k) Applications for this Company
Contact	ARTHUR J WARD Other 510(k) Applications for this Contact
Regulation Number	872.3960   More FDA Info for this Regulation Number
Classification Product Code	NEI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/02/1999
Decision Date	07/27/2001
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