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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name nebulizer (direct patient interface)
510(k) Number K150591
Device Name Besmed Reusable Jet Nebulizer
Applicant
BESMED HEALTH BUSINESS CORP.
NO.5, LANE116, WU-KONG 2ND RD
NEW TAIPEI CITY,  TW 24888
Applicant Contact WINNIE CHUNG
Correspondent
BESMED HEALTH BUSINESS CORP.
NO.5, LANE116, WU-KONG 2ND RD
NEW TAIPEI CITY,  TW 24888
Correspondent Contact PAUL DRYDEN
Regulation Number868.5630
Classification Product Code
CAF  
Date Received03/09/2015
Decision Date 06/30/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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