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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
PNEU PAC, LTD.
SMITHS MEDICAL
N7 W22025 JOHNSON ROAD
WAUKESHA,  WI  53186 -1856
Applicant Contact DONALD ALEXANDER
Correspondent
PNEU PAC, LTD.
SMITHS MEDICAL
N7 W22025 JOHNSON ROAD
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
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