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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: KXA
Date Received: 02/12/2004
Decision Date: 11/04/2004
Decision: 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: KXA
Date Received: 02/12/2004
Decision Date: 11/04/2004
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
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