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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name unit, liquid-oxygen, portable
510(k) Number K880183
Device Name PORTABLE THERAPEUTIC LIQUID OXYGEN UNIT
Applicant
ESSEX CRYOGENICS OF MISSOURI, INC.
8007 CHIVVIS DR.
ST. LOUIS,  MO  63123
Applicant Contact FRED SNYDER
Correspondent
ESSEX CRYOGENICS OF MISSOURI, INC.
8007 CHIVVIS DR.
ST. LOUIS,  MO  63123
Correspondent Contact FRED SNYDER
Regulation Number868.5655
Classification Product Code
BYJ  
Date Received01/15/1988
Decision Date 04/14/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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