DTAD

Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece

GYRUS ACMI, INC.

The following data is part of a premarket notification filed by Gyrus Acmi, Inc. with the FDA for Dtad.

Pre-market Notification Details

• Device ID: K121678
• 510k Number: K121678
• Device Name: DTAD
• Classification: Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece
• Applicant: GYRUS ACMI, INC. 136 TURNPIKE RD. Southborough, MA 01772
• Contact: Dolan Mills
• Correspondent: Dolan Mills; GYRUS ACMI, INC. 136 TURNPIKE RD. Southborough, MA 01772
• Product Code: ERL
• CFR Regulation Number: 874.4250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-06-07
• Decision Date: 2012-08-30
• Summary: summary