FDA 510(k), K083802, SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND GUS-01-27-025

FDA 510(k), K083802, SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND GUS-01-27-025

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510(K) Number: K083802
Device Name: SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND GUS-01-27-025
Manufacturer:
Device Classification Name: Biopsy Needle
Regulation Number: 876.1075
Classification Product Code: FCG
Date Received: 12/22/2008
Decision Date: 03/20/2009
Regulation Medical Specialty: Gastroenterology/Urology

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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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