FDA 510(k) K201631, VersaWrap Nerve Protector, by Alafair Biosciences, Inc.

FDA 510(k) K201631, VersaWrap Nerve Protector, by Alafair Biosciences, Inc.

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Device Classification Name: Cuff, Nerve
510(k) Number: K201631
Device Name: VersaWrap Nerve Protector
Applicant: Alafair Biosciences, Inc.
Regulation Number: 882.5275
Classification Product Code: JXI
Date Received: 06/16/2020
Decision Date: 09/14/2020
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
510k Review Panel: Neurology

Total number of pages: 1,184
Fully redacted pages: 848
Content pages: 336

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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