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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 K042262
Device Name INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-10
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 Received08/23/2004
Decision Date 09/10/2004
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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