The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Fenwal(r) 40/150 Micron Dual Screen Filter.
| Device ID | K932301 |
| 510k Number | K932301 |
| Device Name: | FENWAL(R) 40/150 MICRON DUAL SCREEN FILTER |
| Classification | Filter, Infusion Line |
| Applicant | BAXTER HEALTHCARE CORP. ROUTE 120 AND WILSON RD. Round Lake, IL 60073 |
| Contact | Ellen Snyder |
| Correspondent | Ellen Snyder BAXTER HEALTHCARE CORP. ROUTE 120 AND WILSON RD. Round Lake, IL 60073 |
| Product Code | FPB |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-12 |
| Decision Date | 1993-11-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50085412065293 | K932301 | 000 |
| 50085412031199 | K932301 | 000 |