Instalief

Device, Thermal, Hemorrhoids

Privi Medical Pte Ltd

The following data is part of a premarket notification filed by Privi Medical Pte Ltd with the FDA for Instalief.

Pre-market Notification Details

• Device ID: K172358
• 510k Number: K172358
• Device Name: Instalief
• Classification: Device, Thermal, Hemorrhoids
• Applicant: Privi Medical Pte Ltd 79 Ayer Rajah Crescent #05-03 Singapore, SG 139955
• Contact: Prusothman M Sinha Raja
• Correspondent: Alan Donald; Matrix Medical Consulting, Inc. 8880 Rio San Diego Drive, Suite 800 San Diego, CA 92108
• Product Code: LKX
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-08-03
• Decision Date: 2018-01-10
• Summary: summary