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FDA 510(k) Application Details - K051964
Device Classification Name
Device, Positive Pressure Breathing, Intermittent
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510(K) Number
K051964
Device Name
Device, Positive Pressure Breathing, Intermittent
Applicant
COMEDICA , INC.
2300 MCDERMOTT ROAD
SUITE 200-207
PLANO, TX 75025 US
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Contact
KRISTA OAKES
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Regulation Number
868.5905
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Classification Product Code
NHJ
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More FDA Info for this Product Code
Date Received
07/20/2005
Decision Date
12/01/2005
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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