FDA 510(k), K102996, MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSOR

FDA 510(k), K102996, MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSOR

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510(K) Number: K102996
Device Name: MEDIVATORS ADVANTAGE PLUS ENDOSCOPE REPROCESSOR
Manufacturer: LYNN LUEDERS
Device Classification Name: Accessories, Cleaning, For Endoscope
Regulation Number: FEB
Classification Product Code: KXA
Date Received: 10/07/2010
Decision Date: 01/13/2011
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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