510(k) K090911

IST SNORING APPLIANCE by Dental Crafters — Product Code LQZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 2009
Date Received
April 1, 2009
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