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FDA 510(k), K151149, Ready-Fit
FDA 510(k), K151149, Ready-Fit
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$49.00 USD
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$49.00 USD
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510(K) Number: K151149
Device Name: Ready-Fit
Manufacturer: DENTEK ORAL CARE, INC.
Device Classification Name: mouthguard, over-the-counter
Regulation Number:
Classification Product Code: OBR
Date Received: 04/30/2015
Decision Date: 09/30/2015
Regulation Medical Specialty:
Device Name: Ready-Fit
Manufacturer: DENTEK ORAL CARE, INC.
Device Classification Name: mouthguard, over-the-counter
Regulation Number:
Classification Product Code: OBR
Date Received: 04/30/2015
Decision Date: 09/30/2015
Regulation Medical Specialty:
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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