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FDA 510(k), K100985, BIOHORIZONS SIMPLE SOLUTIONS WITH LASER-LOK
FDA 510(k), K100985, BIOHORIZONS SIMPLE SOLUTIONS WITH LASER-LOK
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510(K) Number: K100985
Device Name: BIOHORIZONS SIMPLE SOLUTIONS WITH LASER-LOK
Manufacturer: BIOHORIZONS IMPLANT SYSTEMS, INC.
Device Classification Name: abutment, implant, dental, endosseous
Regulation Number: 872.3630
Classification Product Code: NHA
Date Received: 04/09/2010
Decision Date: 09/09/2010
Regulation Medical Specialty: Dental
Device Name: BIOHORIZONS SIMPLE SOLUTIONS WITH LASER-LOK
Manufacturer: BIOHORIZONS IMPLANT SYSTEMS, INC.
Device Classification Name: abutment, implant, dental, endosseous
Regulation Number: 872.3630
Classification Product Code: NHA
Date Received: 04/09/2010
Decision Date: 09/09/2010
Regulation Medical Specialty: Dental
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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. IMPORTANT: The FDA FOIA office operations are currently suspended. We are happy to make the request but do not know when we will receive a response. Learn more about Fast-Track Requests here.
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