REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER

Dialyzer, High Permeability With Or Without Sealed Dialysate System

GAMBRO RENAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Gambro Renal Products, Inc. with the FDA for Revaclear 300 Dialyzer, Revaclear 400 Dialyzer.

Pre-market Notification Details

• Device ID: K130039
• 510k Number: K130039
• Device Name: REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER
• Classification: Dialyzer, High Permeability With Or Without Sealed Dialysate System
• Applicant: GAMBRO RENAL PRODUCTS, INC. 14143 DENVER WEST PARKWAY SUITE 400 Lakewood, CO 80401
• Contact: Kae Miller
• Correspondent: Kae Miller; GAMBRO RENAL PRODUCTS, INC. 14143 DENVER WEST PARKWAY SUITE 400 Lakewood, CO 80401
• Product Code: KDI
• CFR Regulation Number: 876.5860 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-01-07
• Decision Date: 2013-05-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
37332414124077	K130039	000
37332414123056	K130039	000
37332414114924	K130039	000
37332414114917	K130039	000
37332414126200	K130039	000
37332414126194	K130039	000