The following data is part of a premarket notification filed by Culligan Soft Water Service Co. with the FDA for Deionizer And Carbon Exchange Service For Hemodialysis.
| Device ID | K082400 |
| 510k Number | K082400 |
| Device Name: | DEIONIZER AND CARBON EXCHANGE SERVICE FOR HEMODIALYSIS |
| Classification | Subsystem, Water Purification |
| Applicant | CULLIGAN SOFT WATER SERVICE CO. 6030 CULLIGAN WAY Minnetonka, MN 55345 |
| Contact | Mike Jablonski |
| Correspondent | Mike Jablonski CULLIGAN SOFT WATER SERVICE CO. 6030 CULLIGAN WAY Minnetonka, MN 55345 |
| Product Code | FIP |
| CFR Regulation Number | 876.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-20 |
| Decision Date | 2009-02-03 |
| Summary: | summary |