NESSY (OMEGA) DISPOSABLE SPLIT RETURN ELECTRODES, MODELS P/N: 20193-084 AND P/N: 20193-085

Electrosurgical, Cutting & Coagulation & Accessories

ERBE USA, INC.

The following data is part of a premarket notification filed by Erbe Usa, Inc. with the FDA for Nessy (omega) Disposable Split Return Electrodes, Models P/n: 20193-084 And P/n: 20193-085.

Pre-market Notification Details

• Device ID: K023812
• 510k Number: K023812
• Device Name: NESSY (OMEGA) DISPOSABLE SPLIT RETURN ELECTRODES, MODELS P/N: 20193-084 AND P/N: 20193-085
• Classification: Electrosurgical, Cutting & Coagulation & Accessories
• Applicant: ERBE USA, INC. 2225 NORTHWEST PKWY. Marietta, GA 30067
• Contact: John Tartal
• Correspondent: John Tartal; ERBE USA, INC. 2225 NORTHWEST PKWY. Marietta, GA 30067
• Product Code: GEI
• CFR Regulation Number: 878.4400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-11-15
• Decision Date: 2002-11-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04050147015593	K023812	000