The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Hemofiltration System 10.
Device ID | K862716 |
510k Number | K862716 |
Device Name: | HEMOFILTRATION SYSTEM 10 |
Classification | System, Dialysate Delivery, Sealed |
Applicant | GAMBRO, INC. 600 KNIGHTSBRIDGE PKWY. Lincolnshire, IL 60069 |
Contact | Jeffrey Shideman |
Correspondent | Jeffrey Shideman GAMBRO, INC. 600 KNIGHTSBRIDGE PKWY. Lincolnshire, IL 60069 |
Product Code | FII |
CFR Regulation Number | 876.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-07-17 |
Decision Date | 1986-09-09 |