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FDA 510(k), K161957, W&H Implantmed SI-1015 incl. Accessories
FDA 510(k), K161957, W&H Implantmed SI-1015 incl. Accessories
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510(K) Number: K161957
Device Name: W&H Implantmed SI-1015 incl. Accessories
Manufacturer: W&H DENTALWERK BURMOOS GMBH
Device Classification Name: controller, foot, handpiece and cord
Regulation Number: 872.4200
Classification Product Code: EBW
Date Received: 07/18/2016
Decision Date: 11/23/2016
Regulation Medical Specialty: Dental
Device Name: W&H Implantmed SI-1015 incl. Accessories
Manufacturer: W&H DENTALWERK BURMOOS GMBH
Device Classification Name: controller, foot, handpiece and cord
Regulation Number: 872.4200
Classification Product Code: EBW
Date Received: 07/18/2016
Decision Date: 11/23/2016
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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