The following data is part of a premarket notification filed by Gambro Renal Products with the FDA for Prismasate.
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 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
37332414108626 | K013448 | 000 |
37332414108619 | K013448 | 000 |
37332414108596 | K013448 | 000 |
37332414108589 | K013448 | 000 |
37332414108572 | K013448 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PRISMASATE 78032988 2670296 Live/Registered |
GAMBRO RENAL PRODUCTS, INC. 2000-10-30 |