FDA 510(k), K183598, KeyPrint KeySplint Soft
FDA 510(k), K183598, KeyPrint KeySplint Soft
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$149.00 USD
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510(K) Number: K183598
Device Name: KeyPrint KeySplint Soft
Manufacturer: Keystone Industries
Device Classification Name: Mouthguard, Prescription
Regulation Number:
Classification Product Code: MQC
Date Received: 12/26/2018
Decision Date: 11/15/2019
Regulation Medical Specialty:
Device Name: KeyPrint KeySplint Soft
Manufacturer: Keystone Industries
Device Classification Name: Mouthguard, Prescription
Regulation Number:
Classification Product Code: MQC
Date Received: 12/26/2018
Decision Date: 11/15/2019
Regulation Medical Specialty:
- 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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