FDA 510(k), K201238, Encore System

510(K) Number: K201238
Device Name: Encore System
Manufacturer: Michael Kolber
Device Classification Name: Tongue Suspension System
Regulation Number: ORY
Classification Product Code: KXA
Date Received: 05/07/2020
Decision Date: 10/02/2020
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental

• Total Pages: 254
• Fully Redacted Pages: 65
• Content Pages: 189 (Total pages minus fully redacted pages)