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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 K083256
Device Name ULTRASONIC NEBULIZER SYSTEM, MODEL KN-9210
Applicant
K-JUMP HEALTH CO., LTD.
NO. 56, WU KUNG 5TH RD.,
WU KU INDUSTRIAL PARK
TAIPEI HSIEN,  TW 248
Applicant Contact JASON CHENG
Correspondent
K-JUMP HEALTH CO., LTD.
NO. 56, WU KUNG 5TH RD.,
WU KU INDUSTRIAL PARK
TAIPEI HSIEN,  TW 248
Correspondent Contact JASON CHENG
Regulation Number868.5630
Classification Product Code
CAF  
Date Received11/04/2008
Decision Date 06/26/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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