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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Correspondent Contact SHARON COHEN, PH.D
Regulation Number878.4014
Classification Product Code
OVR  
Date Received03/04/2011
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
Predetermined Change
Control Plan Authorized		 No
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