LC Bead LUMI

Device, Vascular, For Promoting Embolization

Biocompatibles UK Limited

The following data is part of a premarket notification filed by Biocompatibles Uk Limited with the FDA for Lc Bead Lumi.

Pre-market Notification Details

• Device ID: K162373
• 510k Number: K162373
• Device Name: LC Bead LUMI
• Classification: Device, Vascular, For Promoting Embolization
• Applicant: Biocompatibles UK Limited Chapman House, Farnham Business Park, Weydon Lane Farnham, GB Gu9 8ql
• Contact: Simon Leppard
• Correspondent: Simon Leppard; Biocompatibles UK Limited Chapman House, Farnham Business Park, Weydon Lane Farnham, GB Gu9 8ql
• Product Code: KRD
• CFR Regulation Number: 870.3300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-08-24
• Decision Date: 2016-12-16
• Summary: summary