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FDA 510(k) Application Details - K060922
Device Classification Name
Generator, Oxygen, Portable
More FDA Info for this Device
510(K) Number
K060922
Device Name
Generator, Oxygen, Portable
Applicant
OXLIFE LLC
141 TWIN SPRINGS RD.
HENDERSONVILLE, NC 28792 US
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Contact
MARGARET K POTEAT
Other 510(k) Applications for this Contact
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
04/04/2006
Decision Date
05/30/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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