FDA 510(k) Application Details - K111191

Device Classification Name Valve, Non-Rebreathing

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510(K) Number K111191
Device Name Valve, Non-Rebreathing
Applicant WET NOSE TECHNOLOGIES, LLC
3750 2ND AVE
LOS ANGELES, CA 90018 US
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Contact LIONEL NEWMAN
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Regulation Number 868.5870

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Classification Product Code CBP
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Date Received 04/28/2011
Decision Date 07/28/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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