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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 K030803
Device Name PARAPAC 200D TRANSPORT, MODEL V200D
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 Received03/13/2003
Decision Date 09/29/2003
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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