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 |