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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
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