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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 STREET, NW
WASHINGTON,  DC  20004
Applicant Contact John j Smith, M.D., J.D.
Correspondent
HOGAN LOVELLS US LLP
555 13TH STREET, 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
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