FDA 510(k), K200348, Neocis Guidance System (NGS) with Fiducial Array Splint (FAS)
FDA 510(k), K200348, Neocis Guidance System (NGS) with Fiducial Array Splint (FAS)
510(K) Number: K200348
Device Name: Neocis Guidance System (NGS) with Fiducial Array Splint (FAS)
Manufacturer: Neocis Inc.
Device Classification Name: Dental Stereotaxic Instrument
Regulation Number: 872.4120
Classification Product Code: PLV
Date Received: 02/12/2020
Decision Date: 05/08/2020
Regulation Medical Specialty: Dental
Total pages: 648
Fully redacted pages: 474
Content pages: 174
Couldn't load pickup availability
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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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.
View full details