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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 K121520
Device Name ULTRASONIC NEBULIZER (MESH TYPE)
Applicant
K-JUMP HEALTH CO., LTD.
NO. 56, WU KUNG 5TH RD.,
NEW TAIPEI INDUST PARK
NEW TAIPEI,  TW 24890
Applicant Contact JM LIN
Correspondent
K-JUMP HEALTH CO., LTD.
NO. 56, WU KUNG 5TH RD.,
NEW TAIPEI INDUST PARK
NEW TAIPEI,  TW 24890
Correspondent Contact JM LIN
Regulation Number868.5630
Classification Product Code
CAF  
Date Received05/22/2012
Decision Date 03/15/2013
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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