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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 K131968
Device Name LONGFIAN OXYGEN CONCENTRATOR
Applicant
LONGFIAN SCITECH CO., LTD.
6840 SW 45TH LN
UNIT 5
MIAMI,  FL  33155
Applicant Contact JUN PENG
Correspondent
LONGFIAN SCITECH CO., LTD.
6840 SW 45TH LN
UNIT 5
MIAMI,  FL  33155
Correspondent Contact JUN PENG
Regulation Number868.5440
Classification Product Code
CAW  
Date Received06/28/2013
Decision Date 09/05/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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