FDA 510(k), K150523, AVAmax Vertebral Balloon
FDA 510(k), K150523, AVAmax Vertebral Balloon
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510(K) Number: K150523
Device Name: AVAmax Vertebral Balloon
Manufacturer: CAREFUSION
Device Classification Name: arthroscope
Regulation Number: 888.1100
Classification Product Code: HRX
Date Received: 03/02/2015
Decision Date: 10/29/2015
Regulation Medical Specialty: Orthopedic
Device Name: AVAmax Vertebral Balloon
Manufacturer: CAREFUSION
Device Classification Name: arthroscope
Regulation Number: 888.1100
Classification Product Code: HRX
Date Received: 03/02/2015
Decision Date: 10/29/2015
Regulation Medical Specialty: Orthopedic
- 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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