FDA 510(k) K032958, PIEZOLITH 3000 LITHOTRIPTER, MODEL 3000, by United Medical Systems, Inc.
FDA 510(k) K032958, PIEZOLITH 3000 LITHOTRIPTER, MODEL 3000, by United Medical Systems, Inc.
Device Classification Name: Lithotriptor, Extracorporeal Shock-Wave, Urological
510(k) Number: K032958
Device Name: PIEZOLITH 3000 LITHOTRIPTER, MODEL 3000
Applicant: United Medical Systems, Inc.
Regulation Number: 876.599
Classification Product Code: LNS
Date Received: 09/22/2003
Decision Date: 02/17/2004
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
510k Review Panel: Gastroenterology/Urology
Total number of pages: 1,052
Fully redacted pages: 644
Content pages: 408
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