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FDA 510(k), K033801, KYPHX HV-R, MODEL C01A
FDA 510(k), K033801, KYPHX HV-R, MODEL C01A
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510(K) Number: K033801
Device Name: KYPHX HV-R, MODEL C01A
Manufacturer: CINDY DOMECUS
Device Classification Name: Cement, Bone, Vertebroplasty
Regulation Number: NDN
Classification Product Code: 12/08/2003
Date Received: 04/01/2004
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: KYPHX HV-R, MODEL C01A
Manufacturer: CINDY DOMECUS
Device Classification Name: Cement, Bone, Vertebroplasty
Regulation Number: NDN
Classification Product Code: 12/08/2003
Date Received: 04/01/2004
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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