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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Valve, Non-Rebreathing
510(k) Number K142402
Device Name BigEasy Non-Rebreathing Valve
Applicant
12th Man Technologies, Inc.
7245 Garden Grove Blvd., Suite C
Garden Grove,  CA  92841
Applicant Contact Alex Stenzler
Correspondent
12th Man Technologies, Inc.
7245 Garden Grove Blvd., Suite C
Garden Grove,  CA  92841
Correspondent Contact Alex Stenzler
Regulation Number868.5870
Classification Product Code
CBP  
Date Received08/27/2014
Decision Date 03/23/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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