The following data is part of a premarket notification filed by Fenwal, Inc. with the FDA for Blood Component Recipient Set With Standard Size Filter And Infusion Set With Side Arm Luer Connector.
| Device ID | K073339 |
| 510k Number | K073339 |
| Device Name: | BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTOR |
| Classification | Set, Blood Transfusion |
| Applicant | FENWAL, INC. THREE CORPORATE DRIVE Lake Zurich, IL 60047 |
| Contact | Tammy Davis |
| Correspondent | Tammy Davis FENWAL, INC. THREE CORPORATE DRIVE Lake Zurich, IL 60047 |
| Product Code | BRZ |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-28 |
| Decision Date | 2008-03-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10811137010698 | K073339 | 000 |
| 10811137010452 | K073339 | 000 |
| 10811137010407 | K073339 | 000 |
| 14052682004190 | K073339 | 000 |
| 14052682004145 | K073339 | 000 |