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FDA 510(k) Application Details - K003927
Device Classification Name
Ventilator, Emergency, Manual (Resuscitator)
More FDA Info for this Device
510(K) Number
K003927
Device Name
Ventilator, Emergency, Manual (Resuscitator)
Applicant
CHEEN HOUNG ENT. CO. LTD.
23 ALLEY 11 LANE 65 SAN DREEN
STREET
TAIPEI (SHULIN) 23805 TW
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Contact
JAY WANG
Other 510(k) Applications for this Contact
Regulation Number
868.5915
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Classification Product Code
BTM
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More FDA Info for this Product Code
Date Received
12/20/2000
Decision Date
06/26/2001
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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