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510(k) K142402

BigEasy Non-Rebreathing Valve by 12th Man Technologies, Inc. — Product Code CBP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 2015
Date Received
August 27, 2014
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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