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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 K033863
Device Name OX-GEN FLEXIBLE O2 GENERATION SYSTEM, MODEL 6-OX-03
Applicant
Ox-Gen, Inc.
P.O. Box 5867
Boise,  ID  83702
Applicant Contact FRANK FOSELLA
Correspondent
Ox-Gen, Inc.
P.O. Box 5867
Boise,  ID  83702
Correspondent Contact FRANK FOSELLA
Regulation Number868.5440
Classification Product Code
CAW  
Date Received12/12/2003
Decision Date 08/22/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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