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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Valve, Non-Rebreathing
510(k) Number K112126
Device Name GENUINE FIRST AID CPR MASK
Applicant
Genuine First Aid, LLC
150 Cherry Ln. Rd.
East Stroudsburg,  PA  18301
Applicant Contact Gary Lehnus
Correspondent
Genuine First Aid, LLC
150 Cherry Ln. Rd.
East Stroudsburg,  PA  18301
Correspondent Contact Gary Lehnus
Regulation Number868.5870
Classification Product Code
CBP  
Date Received07/25/2011
Decision Date 12/01/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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