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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 K083163
Device Name OMNI 2 OXYGEN SYSTEM
Applicant
SEQUAL TECHNOLOGIES, INC.
11436 SORRENTO VALLEY RD.
SAN DIEGO,  CA  92121 -1393
Applicant Contact BRIAN JARRELL
Correspondent
SEQUAL TECHNOLOGIES, INC.
11436 SORRENTO VALLEY RD.
SAN DIEGO,  CA  92121 -1393
Correspondent Contact BRIAN JARRELL
Regulation Number868.5440
Classification Product Code
CAW  
Date Received10/27/2008
Decision Date 10/20/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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