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510(k) K031649

SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES by Fink Engineering Pty, Ltd. — Product Code CBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 2003
Date Received
May 28, 2003
Clearance Type
Abbreviated
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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