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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 K152521
Device Name Seal Rite Non-Rebreathing Valve
Applicant
The Lifeguard Store, Inc.
2012 W. College Ave.
Normal,  IL  61761
Applicant Contact Amy Hilten
Correspondent
Quarles & Brady Llp
33 E Main St., Suite 900
Madison,  WI  53703
Correspondent Contact Jennifer J. Hennessy
Regulation Number868.5870
Classification Product Code
CBP  
Date Received09/03/2015
Decision Date 06/03/2016
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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