FDA 510(k) Application Details - K014079

Device Classification Name	Mouthguard, Prescription   More FDA Info for this Device
510(K) Number	K014079
Device Name	Mouthguard, Prescription
Applicant	INVENTIVE RESOURCES, INC. 200 GREGORY LN. SUITE C-100 PLEASANT HILL, CA 94523-3389 US Other 510(k) Applications for this Company
Contact	DAVID W SCHLERF Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MQC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/11/2001
Decision Date	02/22/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review