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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name generator, oxygen, portable
510(k) Number K060922
Device Name OXLIFE FREEDOM FIVE OXYGEN CONCENTRATORS, MODEL KXF5
Applicant
OXLIFE LLC
141 TWIN SPRINGS RD.
HENDERSONVILLE,  NC  28792
Applicant Contact MARGARET K POTEAT
Correspondent
OXLIFE LLC
141 TWIN SPRINGS RD.
HENDERSONVILLE,  NC  28792
Correspondent Contact MARGARET K POTEAT
Regulation Number868.5440
Classification Product Code
CAW  
Date Received04/04/2006
Decision Date 05/30/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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