Cleared Traditional

K875076 - FLORIDA PROBE
(FDA 510(k) Clearance)

Mar 1988
Decision
92d
Days
Class 1
Risk

K875076 is an FDA 510(k) clearance for the FLORIDA PROBE. This device is classified as a Probe, Periodontic (Class I - General Controls, product code EIX).

Submitted by Florida Probe Corp. (Gainesville, US). The FDA issued a Cleared decision on March 10, 1988, 92 days after receiving the submission on December 9, 1987.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number K875076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1987
Decision Date March 10, 1988
Days to Decision 92 days
Submission Type Traditional
Review Panel Dental (DE)
Summary

Device Classification

Product Code EIX — Probe, Periodontic
Device Class Class I - General Controls
CFR Regulation 21 CFR 872.4565