FDA 510(k), K211069, EndSnorZ Sleep Appliance
FDA 510(k), K211069, EndSnorZ Sleep Appliance
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510(K) Number: K211069
Device Name: EndSnorZ Sleep Appliance
Manufacturer: Prismatik Dentalcraft, Inc.
Device Classification Name: Device, Anti-Snoring
Regulation Number: 872.5570
Classification Product Code: LRK
Date Received: 04/12/2021
Decision Date: 10/26/2021
Regulation Medical Specialty: Dental
Device Name: EndSnorZ Sleep Appliance
Manufacturer: Prismatik Dentalcraft, Inc.
Device Classification Name: Device, Anti-Snoring
Regulation Number: 872.5570
Classification Product Code: LRK
Date Received: 04/12/2021
Decision Date: 10/26/2021
Regulation Medical Specialty: Dental
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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