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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Therapeutic (Incentive)
510(k) Number K140772
Device Name AEROSURE MEDIC
Applicant
Actegy , Ltd.
555 13th St. NW
Washington,  DC  20004
Applicant Contact John j Smith, M.D., J.D.
Correspondent
Hogan Lovells US LLP
555 13th St. NW
Washington,  DC  20004
Correspondent Contact John j Smith, M.D., J.D.
Regulation Number868.5690
Classification Product Code
BWF  
Date Received03/27/2014
Decision Date 12/19/2014
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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