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510(k) K080926

AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZER by Trudell Medical Intl. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 2008
Date Received
April 2, 2008
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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