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FDA 510(k), K072522, THERMOFORM SHEET MATERIALS AND ACCESSORIES
FDA 510(k), K072522, THERMOFORM SHEET MATERIALS AND ACCESSORIES
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510(K) Number: K072522
Device Name: THERMOFORM SHEET MATERIALS AND ACCESSORIES
Manufacturer: DENTSPLY INTERNATIONAL, INC.
Device Classification Name: mouthguard, prescription
Regulation Number:
Classification Product Code: MQC
Date Received: 09/07/2007
Decision Date: 11/16/2007
Regulation Medical Specialty:
Device Name: THERMOFORM SHEET MATERIALS AND ACCESSORIES
Manufacturer: DENTSPLY INTERNATIONAL, INC.
Device Classification Name: mouthguard, prescription
Regulation Number:
Classification Product Code: MQC
Date Received: 09/07/2007
Decision Date: 11/16/2007
Regulation Medical Specialty:
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- 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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