The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Acid Concentrate 45x (2.0k, 3.1ca), Model 5m8001a, Acid Concentrate 45x (2.0k, 2.5ca), Model 5m8002a.
| Device ID | K090002 |
| 510k Number | K090002 |
| Device Name: | ACID CONCENTRATE 45X (2.0K, 3.1CA), MODEL 5M8001A, ACID CONCENTRATE 45X (2.0K, 2.5CA), MODEL 5M8002A |
| Classification | Dialysate Concentrate For Hemodialysis (liquid Or Powder) |
| Applicant | BAXTER HEALTHCARE CORP. 1620 WAUKEGAN ROAD Mcgaw Park, IL 60085 |
| Contact | Donna Djinovich |
| Correspondent | Donna Djinovich BAXTER HEALTHCARE CORP. 1620 WAUKEGAN ROAD Mcgaw Park, IL 60085 |
| Product Code | KPO |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-02 |
| Decision Date | 2009-08-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50085412150623 | K090002 | 000 |
| 50085412150616 | K090002 | 000 |
| 50085412150593 | K090002 | 000 |
| 50085412150586 | K090002 | 000 |
| 50085412150579 | K090002 | 000 |
| 50085412150562 | K090002 | 000 |