The following data is part of a premarket notification filed by Gambro Renal Products with the FDA for Prismasate Dialysis Solutions For Continuous Renal Replacement Therapy.
| Device ID | K072908 |
| 510k Number | K072908 |
| Device Name: | PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPY |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | GAMBRO RENAL PRODUCTS 1845 MASON AVE. Daytona Beach, FL 32117 -5102 |
| Contact | Fei Law |
| Correspondent | Fei Law GAMBRO RENAL PRODUCTS 1845 MASON AVE. Daytona Beach, FL 32117 -5102 |
| Product Code | KPO |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-12 |
| Decision Date | 2008-02-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50085412645822 | K072908 | 000 |
| 37332414108602 | K072908 | 000 |
| 37332414100170 | K072908 | 000 |
| 37332414074648 | K072908 | 000 |
| 37332414074013 | K072908 | 000 |
| 37332414066834 | K072908 | 000 |
| 37332414037049 | K072908 | 000 |
| 37332414037032 | K072908 | 000 |