DASH

Retractor

EZSURGICAL

The following data is part of a premarket notification filed by Ezsurgical with the FDA for Dash.

Pre-market Notification Details

• Device ID: K071775
• 510k Number: K071775
• Device Name: DASH
• Classification: Retractor
• Applicant: EZSURGICAL 13 RED FOX LANE Littleton, CO 80127
• Contact: Kevin Walls
• Correspondent: Kevin Walls; EZSURGICAL 13 RED FOX LANE Littleton, CO 80127
• Product Code: GAD
• CFR Regulation Number: 878.4800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-06-29
• Decision Date: 2007-08-07