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FDA 510(k), K061735, INFIBRA, MODEL 1200
FDA 510(k), K061735, INFIBRA, MODEL 1200
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510(K) Number: K061735
Device Name: INFIBRA, MODEL 1200
Manufacturer: GLOBAL DENTAL PRODUCTS, INC.
Device Classification Name: resin, denture, relining, repairing, rebasing
Regulation Number: 872.3760
Classification Product Code: EBI
Date Received: 06/20/2006
Decision Date: 09/08/2006
Regulation Medical Specialty: Dental
Device Name: INFIBRA, MODEL 1200
Manufacturer: GLOBAL DENTAL PRODUCTS, INC.
Device Classification Name: resin, denture, relining, repairing, rebasing
Regulation Number: 872.3760
Classification Product Code: EBI
Date Received: 06/20/2006
Decision Date: 09/08/2006
Regulation Medical Specialty: Dental
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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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