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510(k) K091557

LUNG FLUTE THERAPEUTIC by Medical Acoustics — Product Code BWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 2010
Date Received
May 27, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Therapeutic (Incentive)
Device Class
Class II
Regulation Number
868.5690
Review Panel
AN
Submission Type

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