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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
Device Name BREATH SHAKE
Applicant
CHEEN HOUNG ENT. CO. LTD.
24301 WOODSAGE DRIVE
BONITA SPRINGS,  FL  34134
Applicant Contact PAUL DRYDEN
Correspondent
CHEEN HOUNG ENT. CO. LTD.
24301 WOODSAGE DRIVE
BONITA SPRINGS,  FL  34134
Correspondent Contact PAUL DRYDEN
Regulation Number868.5665
Classification Product Code
BYI  
Date Received05/31/2012
Decision Date 11/22/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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