FDA 510(k), K884709, ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL)

FDA 510(k), K884709, ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL)

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510(K) Number: K884709
Device Name: ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL)
Manufacturer:
Device Classification Name: Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
Regulation Number: 876.1500
Classification Product Code: ODD
Date Received: 11/08/1988
Decision Date: 09/08/1989
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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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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