GAMBRO PERITONEAL DIALYSIS FLUID LINES

Set, Administration, For Peritoneal Dialysis, Disposable

GAMBRO, INC.

The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Gambro Peritoneal Dialysis Fluid Lines.

Pre-market Notification Details

• Device ID: K811294
• 510k Number: K811294
• Device Name: GAMBRO PERITONEAL DIALYSIS FLUID LINES
• Classification: Set, Administration, For Peritoneal Dialysis, Disposable
• Applicant: GAMBRO, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: KDJ
• CFR Regulation Number: 876.5630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1981-05-11
• Decision Date: 1981-06-12