FDA 510(k), K173651, Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set

FDA 510(k), K173651, Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set

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510(K) Number: K173651
Device Name: Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set
Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC
Device Classification Name: set, administration, for peritoneal dialysis, disposable
Regulation Number: 876.5630
Classification Product Code: KDJ
Date Received: 11/28/2017
Decision Date: 02/14/2018
Regulation Medical Specialty: Gastroenterology/Urology

Total pages: 3165
Fully redacted pages: 3023
Content pages: 142

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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