R2 ELECTROSURG. RETURN ELECT. #225ETC.

Electrode, Gel, Electrosurgical

R2 CORP.

The following data is part of a premarket notification filed by R2 Corp. with the FDA for R2 Electrosurg. Return Elect. #225etc..

Pre-market Notification Details

• Device ID: K800933
• 510k Number: K800933
• Device Name: R2 ELECTROSURG. RETURN ELECT. #225ETC.
• Classification: Electrode, Gel, Electrosurgical
• Applicant: R2 CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: JOT
• CFR Regulation Number: 878.4400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1980-04-21
• Decision Date: 1980-05-20