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FDA 510(k) Application Details - K072723
Device Classification Name
Unit, Liquid-Oxygen, Portable
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510(K) Number
K072723
Device Name
Unit, Liquid-Oxygen, Portable
Applicant
RESPIRONICS, INC.
1740 GOLDEN MILE HIGHWAY
MONROEVILLE, PA 15146 US
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Contact
ZITA A YURKO
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Regulation Number
868.5655
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Classification Product Code
BYJ
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More FDA Info for this Product Code
Date Received
09/26/2007
Decision Date
03/20/2008
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
Y
Expedited Review
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