The following data is part of a premarket notification filed by Isopure Corp. with the FDA for Bicarb Mixing And Distribution System.
| Device ID | K112427 |
| 510k Number | K112427 |
| Device Name: | BICARB MIXING AND DISTRIBUTION SYSTEM |
| Classification | Tank, Holding, Dialysis |
| Applicant | ISOPURE CORP. 141 CITIZENS BLVD. Simpsonville, KY 40067 -6548 |
| Contact | Kevin C Gillespie |
| Correspondent | Kevin C Gillespie ISOPURE CORP. 141 CITIZENS BLVD. Simpsonville, KY 40067 -6548 |
| Product Code | FIN |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-23 |
| Decision Date | 2012-01-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852456007085 | K112427 | 000 |