SAW BLADE

Blade, Saw, General & Plastic Surgery, Surgical

OMEGA SURGICAL INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Omega Surgical Instruments, Inc. with the FDA for Saw Blade.

Pre-market Notification Details

• Device ID: K933298
• 510k Number: K933298
• Device Name: SAW BLADE
• Classification: Blade, Saw, General & Plastic Surgery, Surgical
• Applicant: OMEGA SURGICAL INSTRUMENTS, INC. 11415 ORCHARDVIEW DR. Fenton, MI 48430
• Contact: Gary L Adam
• Correspondent: Gary L Adam; OMEGA SURGICAL INSTRUMENTS, INC. 11415 ORCHARDVIEW DR. Fenton, MI 48430
• Product Code: GFA
• CFR Regulation Number: 878.4820 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-07-07
• Decision Date: 1993-08-09