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 |