GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520

Set, Tubing, Blood, With And Without Anti-regurgitation Valve

GAMBRO RENAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Gambro Renal Products, Inc. with the FDA for Gambro Cartridge Blood Set Low Weight- Low Volume, Model 003422-520.

Pre-market Notification Details

• Device ID: K100364
• 510k Number: K100364
• Device Name: GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520
• Classification: Set, Tubing, Blood, With And Without Anti-regurgitation Valve
• 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: FJK
• CFR Regulation Number: 876.5820 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-02-12
• Decision Date: 2010-11-03
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
37332414112401	K100364	000