FDA 510(k), K142399, DualCap IV Pole Strips(Disinfectant Caps for Male Luers)

FDA 510(k), K142399, DualCap IV Pole Strips(Disinfectant Caps for Male Luers)

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510(K) Number: K142399
Device Name: DualCap IV Pole Strips(Disinfectant Caps for Male Luers)
Manufacturer: Donald d Soloman
Device Classification Name: Cap, Device Disinfectant
Regulation Number: QBP
Classification Product Code: KXA
Date Received: 08/27/2014
Decision Date: 11/19/2014
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital

Total pages: 215
Fully redacted pages: 63
Content pages: 152

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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