FDA 510(k) K200299, Curos Jet Disinfecting Cap, by 3M Company

FDA 510(k) K200299, Curos Jet Disinfecting Cap, by 3M Company

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510(k) Number K200299
Device Classification Name Cap, Device Disinfectant
Device Name Curos Jet Disinfecting Cap
Applicant 3M Company 2510 Conway Ave., Bldg. 275-5nw-06 St. Paul, MN 55144
Regulation Number 880.544
Classification Product Code QBP
Date Received 02/06/2020
Decision Date 10/29/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Total Pages 1403
Redacted Pages 1113
Unredacted Pages 290

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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