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FDA 510(k), K151532, KYPHON ELEMENT Inflatable Bone Tamp
FDA 510(k), K151532, KYPHON ELEMENT Inflatable Bone Tamp
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$149.00 USD
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510(K) Number: K151532
Device Name: KYPHON ELEMENT Inflatable Bone Tamp
Manufacturer: MEDTRONIC, INC.
Device Classification Name: arthroscope
Regulation Number: 888.1100
Classification Product Code: HRX
Date Received: 06/08/2015
Decision Date: 07/23/2015
Regulation Medical Specialty: Orthopedic
Device Name: KYPHON ELEMENT Inflatable Bone Tamp
Manufacturer: MEDTRONIC, INC.
Device Classification Name: arthroscope
Regulation Number: 888.1100
Classification Product Code: HRX
Date Received: 06/08/2015
Decision Date: 07/23/2015
Regulation Medical Specialty: Orthopedic
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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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