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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Regulator, Pressure, Gas Cylinder
510(k) Number K080243
Device Name PORTABLE OXYGEN UNIT SCA900
Applicant
San Cheong Co. , Ltd.
13340 E Firestone Blvd.
Suite J
Santa Fe Springs,  CA  90670
Applicant Contact JUNG BAE BANG
Correspondent
San Cheong Co. , Ltd.
13340 E Firestone Blvd.
Suite J
Santa Fe Springs,  CA  90670
Correspondent Contact JUNG BAE BANG
Regulation Number868.2700
Classification Product Code
CAN  
Subsequent Product Code
ECX  
Date Received01/31/2008
Decision Date 04/07/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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