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 |