The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Sepacell(r) R-200/500 Leukocyte Removal Recip Sets.
| Device ID | K904223 |
| 510k Number | K904223 |
| Device Name: | SEPACELL(R) R-200/500 LEUKOCYTE REMOVAL RECIP SETS |
| Classification | Microfilter, Blood Transfusion |
| Applicant | BAXTER HEALTHCARE CORP. ROUTE 120 AND WILSON RD. Round Lake, IL 60073 |
| Contact | Donald Buchholz |
| Correspondent | Donald Buchholz BAXTER HEALTHCARE CORP. ROUTE 120 AND WILSON RD. Round Lake, IL 60073 |
| Product Code | CAK |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-13 |
| Decision Date | 1990-10-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10811137010711 | K904223 | 000 |