Cleared Traditional

SAW BLADE

K933298 · Omega Surgical Instruments, Inc. · General & Plastic Surgery

Aug 1993

Decision

33d

Days

Class 1

Risk

About This 510(k) Submission

K933298 is an FDA 510(k) clearance for the SAW BLADE, 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 August 9, 1993, 33 days after receiving the submission on July 7, 1993. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number	K933298 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 07, 1993
Decision Date	August 09, 1993
Days to Decision	33 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement