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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 K091538
Device Name PRESSURE RELEASE VALVE W/AUDIBLE, MODEL PRV 20/40/60; WITH T6 ADAPTER, MODEL PRV 120/140/160; T6 ADAPTER, MODEL T6-100
Applicant
WET NOSE TECHNOLOGIES, LLC
3750 2ND AVE
LOS ANGELES,  CA  90018
Applicant Contact JIM BARLEY
Correspondent
WET NOSE TECHNOLOGIES, LLC
3750 2ND AVE
LOS ANGELES,  CA  90018
Correspondent Contact JIM BARLEY
Regulation Number868.5870
Classification Product Code
CBP  
Date Received05/26/2009
Decision Date 03/25/2010
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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