FDA 510(k), K973500, BARD ENDOSCOPIC OVERTUBE (#000307)

FDA 510(k), K973500, BARD ENDOSCOPIC OVERTUBE (#000307)

Regular price $89.00 USD
Regular price Sale price $89.00 USD
Sale Sold out
510(K) Number: K973500
Device Name: BARD ENDOSCOPIC OVERTUBE (#000307)
Manufacturer:
Device Classification Name: Endoscopic Access Overtube, Gastroenterology-Urology
Regulation Number: 876.1500
Classification Product Code: FED
Date Received: 09/16/1997
Decision Date: 10/16/1997
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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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.

View full details