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510(k) K051365

COMPRESSOR NEBULIZER SYSTEM, MODEL KN-9321 by K-Jump Health Co., Ltd. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 2005
Date Received
May 25, 2005
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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