FDA 510(k) Application Details - K080243

Device Classification Name Regulator, Pressure, Gas Cylinder

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510(K) Number K080243
Device Name Regulator, Pressure, Gas Cylinder
Applicant SAN CHEONG CO. LTD.
13340 E FIRESTONE BLVD
SUITE J
SANTA FE SPRINGS, CA 90670 US
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Contact JUNG BAE BANG
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Regulation Number 868.2700

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Classification Product Code CAN
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Date Received 01/31/2008
Decision Date 04/07/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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