MicroFrance Monopolar And Bipolar Electrosurgical Instruments

Electrosurgical, Cutting & Coagulation & Accessories

Integra MicroFrance

The following data is part of a premarket notification filed by Integra Microfrance with the FDA for Microfrance Monopolar And Bipolar Electrosurgical Instruments.

Pre-market Notification Details

• Device ID: K210942
• 510k Number: K210942
• Device Name: MicroFrance Monopolar And Bipolar Electrosurgical Instruments
• Classification: Electrosurgical, Cutting & Coagulation & Accessories
• Applicant: Integra MicroFrance Le Pavillon Saint Aubin Le Monial Allier, FR 03160
• Contact: Malena Zammetti
• Correspondent: Malena Zammetti; Integra MicroFrance Le Pavillon Saint Aubin Le Monial Allier, FR 03160
• Product Code: GEI
• CFR Regulation Number: 878.4400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-03-30
• Decision Date: 2021-05-14

NIH GUDID Devices

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