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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 K083559
Device Name YUYUE OXYGENMAX OXYGEN CONCENTRATOR, MODELS: 7F-5A/7F-5B
Applicant
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.
9109 COPENHAVER DR.
POTOMAC,  MD  20854
Applicant Contact NORMAN F ESTRIN
Correspondent
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.
9109 COPENHAVER DR.
POTOMAC,  MD  20854
Correspondent Contact NORMAN F ESTRIN
Regulation Number868.5440
Classification Product Code
CAW  
Date Received12/02/2008
Decision Date 09/04/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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