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510(k) K092859

MERITS MODEL N SERIES NEBULIZER COMPRESSORS by Merits Health Products Co., Ltd. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 2010
Date Received
September 17, 2009
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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