RENATRON

Dialyzer Reprocessing System

RENAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Renal Systems, Inc. with the FDA for Renatron.

Pre-market Notification Details

• Device ID: K842258
• 510k Number: K842258
• Device Name: RENATRON
• Classification: Dialyzer Reprocessing System
• Applicant: RENAL SYSTEMS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534
• Product Code: LIF
• CFR Regulation Number: 876.5820 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1984-06-07
• Decision Date: 1984-07-06