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FDA 510(k), K052241, DISC-FX SYSTEM
FDA 510(k), K052241, DISC-FX SYSTEM
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510(K) Number: K052241
Device Name: DISC-FX SYSTEM
Manufacturer: ELLMAN INTERNATIONAL, INC.
Device Classification Name: arthroscope
Regulation Number: 888.1100
Classification Product Code: HRX
Date Received: 08/17/2005
Decision Date: 02/24/2006
Regulation Medical Specialty: Orthopedic
Device Name: DISC-FX SYSTEM
Manufacturer: ELLMAN INTERNATIONAL, INC.
Device Classification Name: arthroscope
Regulation Number: 888.1100
Classification Product Code: HRX
Date Received: 08/17/2005
Decision Date: 02/24/2006
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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