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FDA 510(k), K093217, 5 MM HARMONIC ACE INSTRUMENT (USED WITH DA VINCI IS1200 & IS2000/IS3000 SYSTEM)
FDA 510(k), K093217, 5 MM HARMONIC ACE INSTRUMENT (USED WITH DA VINCI IS1200 & IS2000/IS3000 SYSTEM)
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510(K) Number: K093217
Device Name: 5 MM HARMONIC ACE INSTRUMENT (USED WITH DA VINCI IS1200 & IS2000/IS3000 SYSTEM)
Manufacturer: INTUITIVE SURGICAL, INC.
Device Classification Name: system, surgical, computer controlled instrument
Regulation Number: 876.1500
Classification Product Code: NAY
Date Received: 10/13/2009
Decision Date: 01/21/2010
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: 5 MM HARMONIC ACE INSTRUMENT (USED WITH DA VINCI IS1200 & IS2000/IS3000 SYSTEM)
Manufacturer: INTUITIVE SURGICAL, INC.
Device Classification Name: system, surgical, computer controlled instrument
Regulation Number: 876.1500
Classification Product Code: NAY
Date Received: 10/13/2009
Decision Date: 01/21/2010
Regulation Medical Specialty: Gastroenterology/Urology
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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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