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510(k) K112041

KOO SMALL VOLUME NEBULIZER (SVN) by Koo (Shanghai) Industries Co., Ltd. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2011
Date Received
July 18, 2011
Clearance Type
Traditional
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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