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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 K043495
Device Name BABYPAC
Applicant
SMITHS MEDICAL INTERNATIONAL LTD., LUTON
N7 W22025 JOHNSON DRIVE
WAUKESHA,  WI  53186
Applicant Contact DONALD ALEXANDER
Correspondent
SMITHS MEDICAL INTERNATIONAL LTD., LUTON
N7 W22025 JOHNSON DRIVE
WAUKESHA,  WI  53186
Correspondent Contact DONALD ALEXANDER
Regulation Number868.5925
Classification Product Code
BTL  
Date Received12/17/2004
Decision Date 04/22/2005
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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