E-Z CLEAN ELECTROSURGICAL ELECTRODE

Electrosurgical, Cutting & Coagulation & Accessories

MEGADYNE MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Megadyne Medical Products, Inc. with the FDA for E-z Clean Electrosurgical Electrode.

Pre-market Notification Details

• Device ID: K081791
• 510k Number: K081791
• Device Name: E-Z CLEAN ELECTROSURGICAL ELECTRODE
• Classification: Electrosurgical, Cutting & Coagulation & Accessories
• Applicant: MEGADYNE MEDICAL PRODUCTS, INC. 11506 SOUTH STATE ST. Draper, UT 84020
• Contact: Ronda K Magneson
• Correspondent: Ronda K Magneson; MEGADYNE MEDICAL PRODUCTS, INC. 11506 SOUTH STATE ST. Draper, UT 84020
• Product Code: GEI
• CFR Regulation Number: 878.4400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-06-25
• Decision Date: 2008-10-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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