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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name percussor, powered-electric
510(k) Number K060439
Device Name LUNG FLUTE
Applicant
MEDICAL ACOUSTICS LLC
255 GREAT ARROW AVE.,
SUITE 23
BUFFALO,  NY  14207
Applicant Contact NICOLAAS J SMIT
Correspondent
MEDICAL ACOUSTICS LLC
255 GREAT ARROW AVE.,
SUITE 23
BUFFALO,  NY  14207
Correspondent Contact NICOLAAS J SMIT
Regulation Number868.5665
Classification Product Code
BYI  
Date Received02/21/2006
Decision Date 06/22/2006
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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