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FDA 510(k) Application Details - K002598
Device Classification Name
Device, Positive Pressure Breathing, Intermittent
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510(K) Number
K002598
Device Name
Device, Positive Pressure Breathing, Intermittent
Applicant
J. H. EMERSON CO.
22 COTTAGE PARK AVE.
CAMBRIDGE, MA 02140-1691 US
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Contact
GEORGE EMERSON
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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
08/21/2000
Decision Date
11/22/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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