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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, Powered (Resuscitator)
510(k) Number K021841
Device Name COMPPAC VENTILATOR MODELS 200 & PS11 POWER SUPPLY/CHARGER
Applicant
Pneupac , Ltd.
Smiths Medical
N7 W22025 Johnson Rd.
Waukesha,  WI  53186 -1856
Applicant Contact DONALD ALEXANDER
Correspondent
Pneupac , Ltd.
Smiths Medical
N7 W22025 Johnson Rd.
Waukesha,  WI  53186 -1856
Correspondent Contact DONALD ALEXANDER
Regulation Number868.5925
Classification Product Code
BTL  
Date Received06/05/2002
Decision Date 07/17/2003
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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