Cleared Traditional

INTRAORAL VIDEO SCOPE AND WINDOW TUBE

K951019 · Cuda Products Co. · Dental
May 1995
Decision
64d
Days
Class 1
Risk

About This 510(k) Submission

K951019 is an FDA 510(k) clearance for the INTRAORAL VIDEO SCOPE AND WINDOW TUBE, a Unit, Operative Dental (Class I — General Controls, product code EIA), submitted by Cuda Products Co. (Jacksonville, US). The FDA issued a Cleared decision on May 10, 1995, 64 days after receiving the submission on March 7, 1995. This device falls under the Dental review panel. Regulated under 21 CFR 872.6640.

Submission Details

510(k) Number K951019 FDA.gov
FDA Decision Cleared SESE
Date Received March 07, 1995
Decision Date May 10, 1995
Days to Decision 64 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EIA — Unit, Operative Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6640

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