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FDA 510(k), K001536, INTER-OP METASUL HOODED AND PROTRUSIO ACETABULAR INSERTS
FDA 510(k), K001536, INTER-OP METASUL HOODED AND PROTRUSIO ACETABULAR INSERTS
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510(K) Number: K001536
Device Name: INTER-OP METASUL HOODED AND PROTRUSIO ACETABULAR INSERTS
Manufacturer: MITCHELL A DHORITY
Device Classification Name: Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Regulation Number: KWA
Classification Product Code: 05/17/2000
Date Received: 07/27/2000
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: INTER-OP METASUL HOODED AND PROTRUSIO ACETABULAR INSERTS
Manufacturer: MITCHELL A DHORITY
Device Classification Name: Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Regulation Number: KWA
Classification Product Code: 05/17/2000
Date Received: 07/27/2000
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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