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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 K121587
Model 3.BSK.1203XXXX
Device Name BREATH SHAKE
Original Applicant
CHEEN HOUNG ENT. CO. LTD.
24301 woodsage drive
bonita springs,  FL  34134
Original Contact paul dryden
Regulation Number868.5665
Classification Product Code
BYI  
Date Received05/31/2012
Decision Date 11/22/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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