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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Therapeutic (Incentive)
510(k) Number K133873
Device Name TRIBALL INCENTIVE SPIROMETER
Applicant
Besmed Health Business Corp
#5, Lane116, Wu-Kong 2nd Rd.
New Taipei City, Wu-Ku District,  TW TAIWAN
Applicant Contact PAUL DRYDEN
Correspondent
Besmed Health Business Corp
#5, Lane116, Wu-Kong 2nd Rd.
New Taipei City, Wu-Ku District,  TW TAIWAN
Correspondent Contact PAUL DRYDEN
Regulation Number868.5690
Classification Product Code
BWF  
Date Received12/20/2013
Decision Date 04/04/2014
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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