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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
Predetermined Change
Control Plan Authorized		 No
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