ASSIST HEADER CLEANER

Dialyzer Reprocessing System

ALCAVIS INTERNATIONAL, INC.

The following data is part of a premarket notification filed by Alcavis International, Inc. with the FDA for Assist Header Cleaner.

Pre-market Notification Details

• Device ID: K043126
• 510k Number: K043126
• Device Name: ASSIST HEADER CLEANER
• Classification: Dialyzer Reprocessing System
• Applicant: ALCAVIS INTERNATIONAL, INC. 8-8 METROPOLITAN CT. Gaithersburg, MD 20878
• Contact: Gary J Mishkin
• Correspondent: Gary J Mishkin; ALCAVIS INTERNATIONAL, INC. 8-8 METROPOLITAN CT. Gaithersburg, MD 20878
• Product Code: LIF
• CFR Regulation Number: 876.5820 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-11-12
• Decision Date: 2005-02-03
• Summary: summary