Cleared Traditional

BUR, SURGICAL, GENERAL & PLASTIC SURGERY

K933595 · Omega Surgical Instruments, Inc. · General & Plastic Surgery

Mar 1994

Decision

233d

Days

Class 1

Risk

About This 510(k) Submission

K933595 is an FDA 510(k) clearance for the BUR, SURGICAL, GENERAL & PLASTIC SURGERY, a Blade, Saw, General & Plastic Surgery, Surgical (Class I — General Controls, product code GFA), submitted by Omega Surgical Instruments, Inc. (Fenton, US). The FDA issued a Cleared decision on March 16, 1994, 233 days after receiving the submission on July 26, 1993. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number	K933595 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 26, 1993
Decision Date	March 16, 1994
Days to Decision	233 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement