The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for Prismasate.
Device ID | K162887 |
510k Number | K162887 |
Device Name: | PrismaSATE |
Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
Applicant | Baxter Healthcare Corporation 32650 North Wilson Road Round Lake, IL 60073 |
Contact | Kristen Bozzelli |
Correspondent | Kristen Bozzelli Baxter Healthcare Corporation 32650 North Wilson Road Round Lake, IL 60073 |
Product Code | KPO |
CFR Regulation Number | 876.5820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-10-17 |
Decision Date | 2017-01-06 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
37332414123094 | K162887 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
PRISMASATE 78032988 2670296 Live/Registered |
GAMBRO RENAL PRODUCTS, INC. 2000-10-30 |