FDA 510(k) Application Details - K132469

Device Classification Name	Mouthguard, Over-The-Counter   More FDA Info for this Device
510(K) Number	K132469
Device Name	Mouthguard, Over-The-Counter
Applicant	INTERNATIONAL PROFIT BUILDERS, INC. 7045 PALM AVE HIGHLAND, CA 92346 US Other 510(k) Applications for this Company
Contact	BRYAN TAPOCIK Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	OBR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/07/2013
Decision Date	02/28/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review