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510(k) K072757

DIVE AND SHALLOW AND GRAND DIVE by Summit TO Sea — Product Code CBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 2008
Date Received
September 27, 2007
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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