SAFETYMATE TALKING FIRST AID


Device Classification Name

kit, first aid, talking

510(k) Number K110625
Device Name SAFETYMATE TALKING FIRST AID
Applicant
SAFETYMATE, INC.
1633 monrovia ave
costa mcsa, 
CA 
92627

Applicant Contact sharon cohen, ph.d
Correspondent
SAFETYMATE, INC.
1633 monrovia ave
costa mcsa, 
CA 
92627

Correspodent Contact sharon cohen, ph.d
Regulation Number 878.4014
Classification Product Code
OVR  
Date Received 03/04/2011
Decision Date 06/17/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No