The following data is part of a premarket notification filed by Dialysis Services, Inc. with the FDA for Dialysis Services, Inc., Typhoon Bicarb Mixing And Distribution System.
| Device ID | K060333 |
| 510k Number | K060333 |
| Device Name: | DIALYSIS SERVICES, INC., TYPHOON BICARB MIXING AND DISTRIBUTION SYSTEM |
| Classification | Tank, Holding, Dialysis |
| Applicant | DIALYSIS SERVICES, INC. 130 ELDER DR. Springfield, TN 37172 |
| Contact | Mike Sterling |
| Correspondent | Mike Sterling DIALYSIS SERVICES, INC. 130 ELDER DR. Springfield, TN 37172 |
| Product Code | FIN |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-09 |
| Decision Date | 2006-09-08 |
| Summary: | summary |