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FDA 510(k), K040354, METAL/METAL HIP SYSTEM
FDA 510(k), K040354, METAL/METAL HIP SYSTEM
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510(K) Number: K040354
Device Name: METAL/METAL HIP SYSTEM
Manufacturer: DEBBIE DE LOS SANTOS
Device Classification Name: Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Regulation Number: KWA
Classification Product Code: 02/12/2004
Date Received: 11/04/2004
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: METAL/METAL HIP SYSTEM
Manufacturer: DEBBIE DE LOS SANTOS
Device Classification Name: Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Regulation Number: KWA
Classification Product Code: 02/12/2004
Date Received: 11/04/2004
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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