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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 K033405
Device Name LONGFEI LFY-I-5 OXYGEN CONCENTRATOR
Applicant
ZHEJIANG LONGFEI INDUSTRIAL CO., LTD.
2288 CAOYANG ROAD
SHANGHAI,  CN 200333
Applicant Contact COCO WANG
Correspondent
ZHEJIANG LONGFEI INDUSTRIAL CO., LTD.
2288 CAOYANG ROAD
SHANGHAI,  CN 200333
Correspondent Contact COCO WANG
Regulation Number868.5440
Classification Product Code
CAW  
Date Received10/24/2003
Decision Date 10/18/2005
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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