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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 K081508
Device Name HG OXYGEN CONCENTRATOR, MODELS HG5-W & HG5-WN
Applicant
SHENYANG CANTA MEDICAL TECH CO., LTD.
SUITE 8D, NO. 19, LANE 999
ZHONGSHAN NO.2 ROAD (S)
SHANGHAI,  CN 200030
Applicant Contact Diana Hong
Correspondent
SHENYANG CANTA MEDICAL TECH CO., LTD.
SUITE 8D, NO. 19, LANE 999
ZHONGSHAN NO.2 ROAD (S)
SHANGHAI,  CN 200030
Correspondent Contact Diana Hong
Regulation Number868.5440
Classification Product Code
CAW  
Date Received05/29/2008
Decision Date 08/27/2008
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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