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510(k) K971818

SNOREX by Snorex (Nz) , Ltd. — Product Code LQZ

K971818 is an FDA 510(k) premarket notification submitted by Snorex (Nz) , Ltd. for the device "SNOREX". The FDA issued a decision of Substantially Equivalent on December 18, 1997. The device falls under product code LQZ (Device, Jaw Repositioning), a Class II device regulated under 21 CFR 872.5570.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1997
Date Received
May 16, 1997
Clearance Type
Traditional
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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FDA data resources