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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 K091557
Device Name LUNG FLUTE THERAPEUTIC
Applicant
MEDICAL ACOUSTICS
255 GREAT ARROW AVE. STE 23
BUFFALO,  NY  14207
Applicant Contact NICOLAAS J SMIT
Correspondent
MEDICAL ACOUSTICS
255 GREAT ARROW AVE. STE 23
BUFFALO,  NY  14207
Correspondent Contact NICOLAAS J SMIT
Regulation Number868.5690
Classification Product Code
BWF  
Date Received05/27/2009
Decision Date 01/04/2010
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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