Intact® Gen2 System

Instrument, Biopsy

INTACT MEDICAL CORPORATION

The following data is part of a premarket notification filed by Intact Medical Corporation with the FDA for Intact® Gen2 System.

Pre-market Notification Details

• Device ID: K152596
• 510k Number: K152596
• Device Name: Intact® Gen2 System
• Classification: Instrument, Biopsy
• Applicant: INTACT MEDICAL CORPORATION 550 COCHITUATE RD SUITE 25 Framingham, MA 01701
• Contact: John Vacha
• Correspondent: John J Smith; HOGAN LOVELLS US LLP 555 THIRTEENTH ST. NW Washington, DC 22204
• Product Code: KNW
• CFR Regulation Number: 876.1075 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-09-10
• Decision Date: 2016-02-15
• Summary: summary