FDA 510(k), K201238, Encore System
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)
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