FDA 510(k) K120685, ZYNO MEDICAL ADMINISTRATION SET, by Zyno Medical, LLC

FDA 510(k) K120685, ZYNO MEDICAL ADMINISTRATION SET, by Zyno Medical, LLC

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Device Classification Name: Set, Administration, Intravascular
510(k) Number: K120685
Device Name: ZYNO MEDICAL ADMINISTRATION SET
Applicant: Zyno Medical, LLC
Regulation Number: 880.544
Classification Product Code: FPA
Date Received: 03/06/2012
Decision Date: 09/07/2012
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
510k Review Panel: General Hospital

Total number of pages: 1,202
Fully redacted pages: 71
Content pages: 1,131

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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