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FDA 510(k) Application Details - K982243
Device Classification Name
Generator, Oxygen, Portable
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510(K) Number
K982243
Device Name
Generator, Oxygen, Portable
Applicant
CANOGEN INTERNATIONAL LTD.
14900 SWEITZER LN.
SUITE 200
LAUREL, MD 20707 US
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Contact
MELISSA MAHALL
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Regulation Number
868.5440
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Classification Product Code
CAW
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More FDA Info for this Product Code
Date Received
06/25/1998
Decision Date
11/19/1998
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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