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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.
# 56, Wu Kung 5th Rd.,
Wu Ku Industrial Park
Taipei Hsien,  TW 248
Applicant Contact JASON CHENG
Correspondent
K-Jump Health Co., Ltd.
# 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
Predetermined Change
Control Plan Authorized		 No
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