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FDA 510(k) Application Details - K954506
Device Classification Name
Generator, Oxygen, Portable
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510(K) Number
K954506
Device Name
Generator, Oxygen, Portable
Applicant
MEDTRAK INTL., INC.
9841 BROKEN LAND PARKWAY, #107
COLUMBIA, MD 21046 US
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Contact
BELINDA E BERNING
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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
09/28/1995
Decision Date
04/30/1996
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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