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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 K884068
Device Name PULMANEX TM (NEO-NATAL SIZE)
Applicant
Life Design Systems, Inc.
5900 W. Franklin Dr.
Franklin,  WI  53132
Applicant Contact ALAN E WHITMARSH
Correspondent
Life Design Systems, Inc.
5900 W. Franklin Dr.
Franklin,  WI  53132
Correspondent Contact ALAN E WHITMARSH
Regulation Number868.5915
Classification Product Code
BTM  
Date Received08/30/1988
Decision Date 11/16/1988
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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