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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 K022684
Device Name PORTABLE THERAPEUTIC OXYGEN CONCENTRATION SYSTEM (PTOCS)
Applicant
ESSEX CRYOGENICS OF MISSOURI, INC.
8007 CHIVVIS DR.
ST. LOUIS,  MO  63123
Applicant Contact ELIZABETH HUNNICUT
Correspondent
ESSEX CRYOGENICS OF MISSOURI, INC.
8007 CHIVVIS DR.
ST. LOUIS,  MO  63123
Correspondent Contact ELIZABETH HUNNICUT
Regulation Number868.5440
Classification Product Code
CAW  
Date Received08/12/2002
Decision Date 09/11/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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