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FDA 510(k), K033382, SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT
FDA 510(k), K033382, SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT
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510(K) Number: K033382
Device Name: SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT
Manufacturer: TIFFANI D ROGERS
Device Classification Name: Bone Cement
Regulation Number: LOD
Classification Product Code: 10/23/2003
Date Received: 02/05/2004
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT
Manufacturer: TIFFANI D ROGERS
Device Classification Name: Bone Cement
Regulation Number: LOD
Classification Product Code: 10/23/2003
Date Received: 02/05/2004
Decision Date: Substantially Equivalent (SESE)
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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