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FDA 510(k), K030086, PALACOS R BONE CEMENT WITH GENTAMICIN
FDA 510(k), K030086, PALACOS R BONE CEMENT WITH GENTAMICIN
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510(K) Number: K030086
Device Name: PALACOS R BONE CEMENT WITH GENTAMICIN
Manufacturer: BIOMET, INC.
Device Classification Name: bone cement
Regulation Number: 888.3027
Classification Product Code: LOD
Date Received: 01/09/2003
Decision Date: 12/17/2003
Regulation Medical Specialty: Orthopedic
Device Name: PALACOS R BONE CEMENT WITH GENTAMICIN
Manufacturer: BIOMET, INC.
Device Classification Name: bone cement
Regulation Number: 888.3027
Classification Product Code: LOD
Date Received: 01/09/2003
Decision Date: 12/17/2003
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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