FDA 510(k) Application Details - K131396

Device Classification Name	More FDA Info for this Device
510(K) Number	K131396
Device Name	WIRED MOUTH PROTECTOR (WMP)
Applicant	ELBA LABORATORIES, INC. 780 W. 8 MILE RD FERNDALE, MI 48220 US Other 510(k) Applications for this Company
Contact	RICHARD A HAMER Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PFL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/15/2013
Decision Date	09/30/2013
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