FDA 510(k), K071249, ULTRAPRO* HERNIA SYSTEM, MODELS UHSL, UHSM, UHSOV
FDA 510(k), K071249, ULTRAPRO* HERNIA SYSTEM, MODELS UHSL, UHSM, UHSOV
Device Name: ULTRAPRO* HERNIA SYSTEM, MODELS UHSL, UHSM, UHSOV
Manufacturer:
Device Classification Name: Mesh, Surgical, Polymeric
Regulation Number: 878.3300
Classification Product Code: FTL
Date Received: 05/04/2007
Decision Date: 06/05/2007
Regulation Medical Specialty: General & Plastic Surgery
Couldn't load pickup availability
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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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.
View full details