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510(k) K080243

PORTABLE OXYGEN UNIT SCA900 by San Cheong Co. , Ltd. — Product Code CAN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 2009
Date Received
January 31, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Regulator, Pressure, Gas Cylinder
Device Class
Class I
Regulation Number
868.2700
Review Panel
AN
Submission Type

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