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510(k) K132143

EXHALATION VALVE by Intersurgical Incorporated — Product Code CBP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 2014
Date Received
July 11, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Valve, Non-Rebreathing
Device Class
Class II
Regulation Number
868.5870
Review Panel
AN
Submission Type

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