VAPR

Electrosurgical, Cutting & Coagulation & Accessories

MITEK PRODUCTS

The following data is part of a premarket notification filed by Mitek Products with the FDA for Vapr.

Pre-market Notification Details

• Device ID: K974022
• 510k Number: K974022
• Device Name: VAPR
• Classification: Electrosurgical, Cutting & Coagulation & Accessories
• Applicant: MITEK PRODUCTS 60 GLACIER DR. Westwood, MA 02090
• Contact: Edward F Kent
• Correspondent: Edward F Kent; MITEK PRODUCTS 60 GLACIER DR. Westwood, MA 02090
• Product Code: GEI
• CFR Regulation Number: 878.4400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-10-14
• Decision Date: 1998-01-12
• Summary: summary