FDA 510(k), K210320, ClearCorrect System
FDA 510(k), K210320, ClearCorrect System
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510(K) Number: K210320
Device Name: ClearCorrect System
Manufacturer: Christopher Klaczyk
Device Classification Name: Aligner, Sequential
Regulation Number: NXC
Classification Product Code: 02/04/2021
Date Received: 08/06/2021
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
Device Name: ClearCorrect System
Manufacturer: Christopher Klaczyk
Device Classification Name: Aligner, Sequential
Regulation Number: NXC
Classification Product Code: 02/04/2021
Date Received: 08/06/2021
Decision Date: Substantially Equivalent (SESE)
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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