BICART
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 Bicart.
Pre-market Notification Details
| Device ID | K013724 |
| 510k Number | K013724 |
| Device Name: | BICART |
| 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 | 2001-11-09 |
| Decision Date | 2002-01-08 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 37332414110575 | K013724 | 000 |
| 37332414088317 | K013724 | 000 |
Trademark Results [BICART]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BICART 73700108 1538839 Live/Registered |
GAMBRO AB 1987-12-10 |
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