The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Fenwal 20 Micron Pediatric Transfusion Filter Model 4c7701, Fenwal 20 Micron Pediatric Transfusion Filter Set Model 4c72.
| Device ID | K982822 |
| 510k Number | K982822 |
| Device Name: | FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER SET MODEL 4C72 |
| Classification | Microfilter, Blood Transfusion |
| Applicant | BAXTER HEALTHCARE CORP. RT. 120 & WILSON RD. Round Lake, IL 60073 |
| Contact | Mary Ellen Snyder |
| Correspondent | Mary Ellen Snyder BAXTER HEALTHCARE CORP. RT. 120 & 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 | 1998-08-11 |
| Decision Date | 1998-09-30 |
| Summary: | summary |