Cleared Traditional

TRI HAWK BUR, FG BUR

K943273 · Tri Hawk Corp. · Dental
Aug 1994
Decision
25d
Days
Class 1
Risk

About This 510(k) Submission

K943273 is an FDA 510(k) clearance for the TRI HAWK BUR, FG BUR, a Bur, Dental (Class I — General Controls, product code EJL), submitted by Tri Hawk Corp. (Los Angeles, US). The FDA issued a Cleared decision on August 1, 1994, 25 days after receiving the submission on July 7, 1994. This device falls under the Dental review panel. Regulated under 21 CFR 872.3240.

Submission Details

510(k) Number K943273 FDA.gov
FDA Decision Cleared SESE
Date Received July 07, 1994
Decision Date August 01, 1994
Days to Decision 25 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EJL — Bur, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.3240