FDA 510(k) K875076, FLORIDA PROBE, by Florida Probe Corp.

FDA 510(k) K875076, FLORIDA PROBE, by Florida Probe Corp.

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Device Classification Name: Probe, Periodontic
510(k) Number: K875076
Device Name: FLORIDA PROBE
Applicant: Florida Probe Corp.
Regulation Number: 872.4565
Classification Product Code: EIX
Date Received: 12/09/1987
Decision Date: 03/10/1988
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
510k Review Panel: Dental

Total number of pages: 126
Fully redacted pages: 85
Content pages: 41

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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