The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Solution Administration Set With 0.22 Micron High Pressure Extended Life Filter.
| Device ID | K964850 |
| 510k Number | K964850 |
| Device Name: | SOLUTION ADMINISTRATION SET WITH 0.22 MICRON HIGH PRESSURE EXTENDED LIFE FILTER |
| Classification | Set, Administration, Intravascular |
| Applicant | BAXTER HEALTHCARE CORP. ROUTE 120 AND WILSON RD. Round Lake, IL 60073 |
| Contact | Mary E Snyder |
| Correspondent | Mary E Snyder BAXTER HEALTHCARE CORP. ROUTE 120 AND WILSON RD. Round Lake, IL 60073 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-03 |
| Decision Date | 1997-02-25 |
| Summary: | summary |