FDA 510(k) Application Details - K010876

Device Classification Name	Mouthguard, Migraine/Tension Headache   More FDA Info for this Device
510(K) Number	K010876
Device Name	Mouthguard, Migraine/Tension Headache
Applicant	NTI-TSS, INC. 2303 BLUE SMOKE TRAIL MISHAWAKA, IN 46544 US Other 510(k) Applications for this Company
Contact	BOB WEBER Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	OCO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/23/2001
Decision Date	06/20/2001
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