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FDA 510(k) Application Details - K082829
Device Classification Name
Medevac Use Oxygen Generator
More FDA Info for this Device
510(K) Number
K082829
Device Name
Medevac Use Oxygen Generator
Applicant
CARLETON LIFE SUPPORT SYSTEMS INC.
2734 HICKORY GROVE RD.
DAVENPORT, IA 52804-1203 US
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Contact
GARY BYRD
Other 510(k) Applications for this Contact
Regulation Number
868.5440
More FDA Info for this Regulation Number
Classification Product Code
OLF
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More FDA Info for this Product Code
Date Received
09/25/2008
Decision Date
12/22/2008
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
N
Expedited Review
Y
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