FDA 510(k) Application Details - K110625

Device Classification Name	More FDA Info for this Device
510(K) Number	K110625
Device Name	SAFETYMATE TALKING FIRST AID
Applicant	SAFETYMATE, INC. 1633 MONROVIA AVE COSTA MCSA, CA 92627 US Other 510(k) Applications for this Company
Contact	SHARON COHEN, PH.D Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/04/2011
Decision Date	06/17/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review