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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 K071581
Device Name BACKPACK MEDICAL OXYGEN SYSTEM
Applicant
ESSEX CRYOGENICS OF MISSOURI, INC.
8007 CHIVVIS DR.
ST. LOUIS,  MO  63123
Applicant Contact ELIZABETH HUNNICUTT
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number868.5655
Classification Product Code
BYJ  
Date Received06/08/2007
Decision Date 07/11/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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