The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Gambro Multipurpose System Mps-10.
Device ID | K881270 |
510k Number | K881270 |
Device Name: | GAMBRO MULTIPURPOSE SYSTEM MPS-10 |
Classification | System, Dialysate Delivery, Sealed |
Applicant | GAMBRO, INC. 600 KNIGHTSBRIDGE PKWY. Lincolnshire, IL 60069 |
Contact | Jeffrey Shideman,phd |
Correspondent | Jeffrey Shideman,phd 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 | 1988-03-24 |
Decision Date | 1988-08-24 |