SMARTGUIDE

Biopsy Needle

FERGUSON MEDICAL

The following data is part of a premarket notification filed by Ferguson Medical with the FDA for Smartguide.

Pre-market Notification Details

• Device ID: K963894
• 510k Number: K963894
• Device Name: SMARTGUIDE
• Classification: Biopsy Needle
• Applicant: FERGUSON MEDICAL 3407 BAY AVE. Chico, CA 95973 -8619
• Contact: Frank Ferguson
• Correspondent: Frank Ferguson; FERGUSON MEDICAL 3407 BAY AVE. Chico, CA 95973 -8619
• Product Code: FCG
• CFR Regulation Number: 876.1075 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-09-27
• Decision Date: 1997-03-11
• Summary: summary