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FDA 510(k) Application Details - K021442
Device Classification Name
Ventilator, Emergency, Manual (Resuscitator)
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510(K) Number
K021442
Device Name
Ventilator, Emergency, Manual (Resuscitator)
Applicant
OEMEDIC INTERNATIONAL, INC.
13 RED FOX LN.
LITTLETON, CO 80127 US
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Contact
Kevin Walls
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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
05/06/2002
Decision Date
07/30/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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