PRISMASATE
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
GAMBRO RENAL PRODUCTS
The following data is part of a premarket notification filed by Gambro Renal Products with the FDA for Prismasate.
Pre-market Notification Details
| Device ID | K013448 |
| 510k Number | K013448 |
| Device Name: | PRISMASATE |
| 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 | 2001-10-17 |
| Decision Date | 2002-01-15 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 37332414108626 | K013448 | 000 |
| 37332414108619 | K013448 | 000 |
| 37332414108596 | K013448 | 000 |
| 37332414108589 | K013448 | 000 |
| 37332414108572 | K013448 | 000 |
Trademark Results [PRISMASATE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PRISMASATE 78032988 2670296 Live/Registered |
GAMBRO RENAL PRODUCTS, INC. 2000-10-30 |
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