THERMOTHERAPY

Device, Thermal, Hemorrhoids

LUTHER MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Luther Medical Products, Inc. with the FDA for Thermotherapy.

Pre-market Notification Details

• Device ID: K822217
• 510k Number: K822217
• Device Name: THERMOTHERAPY
• Classification: Device, Thermal, Hemorrhoids
• Applicant: LUTHER MEDICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• 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: 1982-07-26
• Decision Date: 1982-09-24