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510(k) K111570

MINISPACER(R) MDI ADAPTER WITH COUNTER INCREMENTING ACTUATOR by Thayer Medical Corporation — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2011
Date Received
June 6, 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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