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510(k) K112634

NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP by Inotec Amd , Ltd. — Product Code KPJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 2012
Date Received
September 9, 2011
Clearance Type
Traditional
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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