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510(k) K091272

BESMED JET NEBULIZER BOTTLE SET by Besmed Health Business Corp — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 2009
Date Received
April 30, 2009
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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