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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
Predetermined Change
Control Plan Authorized		 No
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