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FDA 510(k), K001523, ULTIMA METAL-ON-METAL ACETABULAR CUP
FDA 510(k), K001523, ULTIMA METAL-ON-METAL ACETABULAR CUP
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510(K) Number: K001523
Device Name: ULTIMA METAL-ON-METAL ACETABULAR CUP
Manufacturer: CHERYL HASTINGS
Device Classification Name: Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Regulation Number: KWA
Classification Product Code: 05/16/2000
Date Received: 08/10/2000
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: ULTIMA METAL-ON-METAL ACETABULAR CUP
Manufacturer: CHERYL HASTINGS
Device Classification Name: Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Regulation Number: KWA
Classification Product Code: 05/16/2000
Date Received: 08/10/2000
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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