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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name ventilator, emergency, manual (resuscitator)
510(k) Number K892221
Device Name PULMONARY RESUSCITATOR, MODIFICATION
Applicant
LIFE DESIGN SYSTEMS, INC.
5900 WEST FRANKLIN DR.
FRANKLIN,  WI  53132
Applicant Contact ALAN E WHITMARSH
Correspondent
LIFE DESIGN SYSTEMS, INC.
5900 WEST FRANKLIN DR.
FRANKLIN,  WI  53132
Correspondent Contact ALAN E WHITMARSH
Regulation Number868.5915
Classification Product Code
BTM  
Date Received03/30/1989
Decision Date 05/18/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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