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FDA 510(k) Application Details - K971964
Device Classification Name
Generator, Oxygen, Portable
More FDA Info for this Device
510(K) Number
K971964
Device Name
Generator, Oxygen, Portable
Applicant
OXLIFE, INC.
917 15TH AVENUE S.E.
CAPE CORAL, FL 33990 US
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Contact
STUART BASSINE
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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
05/28/1997
Decision Date
08/15/1997
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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