SAFE GUARD

Electrosurgical, Cutting & Coagulation & Accessories

CONCEPT, INC.

The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Safe Guard.

Pre-market Notification Details

• Device ID: K812722
• 510k Number: K812722
• Device Name: SAFE GUARD
• Classification: Electrosurgical, Cutting & Coagulation & Accessories
• Applicant: CONCEPT, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: GEI
• CFR Regulation Number: 878.4400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1981-09-28
• Decision Date: 1981-11-05