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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.

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FDA 510(k) records for PIEZOLITH 3000 LITHOTRIPTER, MODEL 3000 (K032958), submitted by United Medical Systems, Inc..

  • 510(k) Number: K032958
  • Applicant: United Medical Systems, Inc.
  • Decision Date: 02/17/2004
  • Decision: Substantially Equivalent (SESE)
  • Product Code: LNS LNS
  • Review Panel: Gastroenterology/Urology
  • Total PDF Pages: 1052
  • Fully Redacted Pages: 644
  • Usable Pages: 408

PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.

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