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510(k) K090681

TANSCU O2 by Electrochemical Oxygen Concepts, Inc. — Product Code KPJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 2009
Date Received
March 16, 2009
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chamber, Oxygen, Topical, Extremity
Device Class
Class II
Regulation Number
878.5650
Review Panel
SU
Submission Type

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