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510(k) K083256

ULTRASONIC NEBULIZER SYSTEM, MODEL KN-9210 by K-Jump Health Co., Ltd. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 2009
Date Received
November 4, 2008
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5630
Review Panel
AN
Submission Type

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