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FDA 510(k), K103433, F20
FDA 510(k), K103433, F20
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510(K) Number: K103433
Device Name: F20
Manufacturer: J.D. WEBB
Device Classification Name: Cement, Bone, Vertebroplasty
Regulation Number: NDN
Classification Product Code: KXA
Date Received: 11/24/2010
Decision Date: 01/03/2011
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: F20
Manufacturer: J.D. WEBB
Device Classification Name: Cement, Bone, Vertebroplasty
Regulation Number: NDN
Classification Product Code: KXA
Date Received: 11/24/2010
Decision Date: 01/03/2011
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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