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FDA 510(k), K112990, ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLE
FDA 510(k), K112990, ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLE
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510(K) Number: K112990
Device Name: ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLE
Manufacturer: CHRISTINA FLORES
Device Classification Name: Pin, Fixation, Smooth
Regulation Number: HTY
Classification Product Code: KXA
Date Received: 10/06/2011
Decision Date: 12/19/2011
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLE
Manufacturer: CHRISTINA FLORES
Device Classification Name: Pin, Fixation, Smooth
Regulation Number: HTY
Classification Product Code: KXA
Date Received: 10/06/2011
Decision Date: 12/19/2011
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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