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510(k) K170606

Acrylic Herbst Appliance with Micro-Recorder by Gergen'S Orthodontic Lab — Product Code PLC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 2017
Date Received
March 1, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sleep Appliances With Patient Monitoring
Device Class
Class II
Regulation Number
872.5570
Review Panel
DE
Submission Type

For the treatment of night time snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older while also measuring patient compliance to oral appliance therapy.

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