FDA 510(k), K063876, MODULAR DISINFECTION SYSTEM (MDS) FOR ENDOSCOPE REPROCESSING

FDA 510(k), K063876, MODULAR DISINFECTION SYSTEM (MDS) FOR ENDOSCOPE REPROCESSING

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510(K) Number: K063876
Device Name: MODULAR DISINFECTION SYSTEM (MDS) FOR ENDOSCOPE REPROCESSING
Manufacturer:
Device Classification Name: Accessories, Cleaning, For Endoscope
Regulation Number: 876.1500
Classification Product Code: FEB
Date Received: 12/29/2006
Decision Date: 06/14/2007
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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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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