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FDA 510(k), K160965, SuperLine
FDA 510(k), K160965, SuperLine
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510(K) Number: K160965
Device Name: SuperLine
Manufacturer: YOUNJUNG YUK
Device Classification Name: Implant, Endosseous, Root-Form
Regulation Number: DZE
Classification Product Code: KXA
Date Received: 04/06/2016
Decision Date: 01/13/2017
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
Device Name: SuperLine
Manufacturer: YOUNJUNG YUK
Device Classification Name: Implant, Endosseous, Root-Form
Regulation Number: DZE
Classification Product Code: KXA
Date Received: 04/06/2016
Decision Date: 01/13/2017
Decision: Substantially Equivalent (SESE)
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. Learn more about Fast-Track Requests here.
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