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FDA 510(k), K032958, PIEZOLITH 3000 LITHOTRIPTER, MODEL 3000
FDA 510(k), K032958, PIEZOLITH 3000 LITHOTRIPTER, MODEL 3000
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510(K) Number: K032958
Device Name: PIEZOLITH 3000 LITHOTRIPTER, MODEL 3000
Manufacturer: UNITED MEDICAL SYSTEMS, INC.
Device Classification Name: Lithotriptor, Extracorporeal Shock-Wave, Urological
Regulation Number: 876.5990
Classification Product Code: LNS
Date Received: 09/22/2003
Decision Date: 02/17/2004
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: PIEZOLITH 3000 LITHOTRIPTER, MODEL 3000
Manufacturer: UNITED MEDICAL SYSTEMS, INC.
Device Classification Name: Lithotriptor, Extracorporeal Shock-Wave, Urological
Regulation Number: 876.5990
Classification Product Code: LNS
Date Received: 09/22/2003
Decision Date: 02/17/2004
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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