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FDA 510(k) Application Details - K094003
Device Classification Name
Ventilator, Emergency, Manual (Resuscitator)
More FDA Info for this Device
510(K) Number
K094003
Device Name
Ventilator, Emergency, Manual (Resuscitator)
Applicant
HERSILL, S.L.
PUERTO DE NAVACERRADA, 3
MOSTOLES ( MADRID) 28935 ES
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Contact
ANA MARIA ROMERO
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
12/28/2009
Decision Date
09/17/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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