PENCIL

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 Pencil.

Pre-market Notification Details

• Device ID: K965054
• 510k Number: K965054
• Device Name: PENCIL
• Classification: Electrosurgical, Cutting & Coagulation & Accessories
• Applicant: MEGADYNE MEDICAL PRODUCTS, INC. 11506 SOUTH STATE ST. Draper, UT 84020
• Contact: Drew D Weaver
• Correspondent: Drew D Weaver; 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: 1996-12-18
• Decision Date: 1997-01-24
• Summary: summary