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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 K864681
Device Name CARHILL ONE-WAY RESUSCITATION VALVE
Applicant
Life Design Systems, Inc.
11017 W. Layton Ave.
Milwaukee,  WI  53228
Applicant Contact ALAN E WHITMARSH
Correspondent
Life Design Systems, Inc.
11017 W. Layton Ave.
Milwaukee,  WI  53228
Correspondent Contact ALAN E WHITMARSH
Regulation Number868.5870
Classification Product Code
CBP  
Date Received12/02/1986
Decision Date 05/21/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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