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510(k) K113201

NARVAL CC by Resmed Sas — Product Code LQZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 2011
Date Received
October 31, 2011
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Jaw Repositioning
Device Class
Class II
Regulation Number
872.5570
Review Panel
DE
Submission Type

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