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FDA 510(k), K010051, POLY-TAPES WITH THE FASTLOK FIXATION DEVICE
FDA 510(k), K010051, POLY-TAPES WITH THE FASTLOK FIXATION DEVICE
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510(K) Number: K010051
Device Name: POLY-TAPES WITH THE FASTLOK FIXATION DEVICE
Manufacturer: XIROS PLC
Device Classification Name: staple, fixation, bone
Regulation Number: 888.3030
Classification Product Code: JDR
Date Received: 01/08/2001
Decision Date: 07/13/2001
Regulation Medical Specialty: Orthopedic
Device Name: POLY-TAPES WITH THE FASTLOK FIXATION DEVICE
Manufacturer: XIROS PLC
Device Classification Name: staple, fixation, bone
Regulation Number: 888.3030
Classification Product Code: JDR
Date Received: 01/08/2001
Decision Date: 07/13/2001
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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