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510(k) K053498

HYPEROX 101 by Wjo, Inc. — Product Code CBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 2006
Date Received
December 16, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chamber, Hyperbaric
Device Class
Class II
Regulation Number
868.5470
Review Panel
AN
Submission Type

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