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FDA 510(k) Application Details - K043495
Device Classification Name
Ventilator, Emergency, Powered (Resuscitator)
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510(K) Number
K043495
Device Name
Ventilator, Emergency, Powered (Resuscitator)
Applicant
SMITHS MEDICAL INTERNATIONAL LTD., LUTON
N7 W22025 JOHNSON DRIVE
WAUKESHA, WI 53186 US
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Contact
DONALD ALEXANDER
Other 510(k) Applications for this Contact
Regulation Number
868.5925
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Classification Product Code
BTL
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More FDA Info for this Product Code
Date Received
12/17/2004
Decision Date
04/22/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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