GENESIS

Electrosurgical, Cutting & Coagulation & Accessories

MEDISISS

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

Pre-market Notification Details

• Device ID: K081559
• 510k Number: K081559
• Device Name: GENESIS
• Classification: Electrosurgical, Cutting & Coagulation & Accessories
• Applicant: MEDISISS 2747 SW 6TH STREET Redmond, OR 97756
• Contact: Brandi James
• Correspondent: Brandi James; MEDISISS 2747 SW 6TH STREET Redmond, OR 97756
• Product Code: GEI
• CFR Regulation Number: 878.4400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-06-03
• Decision Date: 2008-08-28
• Summary: summary