Cleared Traditional

SURGICAL BUR

K943758 · Komet Medical · General & Plastic Surgery

Aug 1994

Decision

20d

Days

Class 1

Risk

About This 510(k) Submission

K943758 is an FDA 510(k) clearance for the SURGICAL BUR, a Bur, Surgical, General & Plastic Surgery (Class I — General Controls, product code GFF), submitted by Komet Medical (Savannah, US). The FDA issued a Cleared decision on August 22, 1994, 20 days after receiving the submission on August 2, 1994. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number	K943758 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 02, 1994
Decision Date	August 22, 1994
Days to Decision	20 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement