Cleared Traditional

KOMET SURGICAL BUR

K883255 · Komet Medical, Div. of Brasseler USA I, L.P. · General & Plastic Surgery

Sep 1988

Decision

44d

Days

Class 1

Risk

About This 510(k) Submission

K883255 is an FDA 510(k) clearance for the KOMET SURGICAL BUR, a Bur, Surgical, General & Plastic Surgery (Class I — General Controls, product code GFF), submitted by Komet Medical, Div. of Brasseler USA I, L.P. (Savannah, US). The FDA issued a Cleared decision on September 15, 1988, 44 days after receiving the submission on August 2, 1988. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number	K883255 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 02, 1988
Decision Date	September 15, 1988
Days to Decision	44 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—