Blood Transfusion Microfilters
Microfilter, Blood Transfusion
Fenwal Inc
The following data is part of a premarket notification filed by Fenwal Inc with the FDA for Blood Transfusion Microfilters.
Pre-market Notification Details
Device ID | BK940040 |
510k Number | BK940040 |
Device Name: | Blood Transfusion Microfilters |
Classification | Microfilter, Blood Transfusion |
Applicant | Fenwal Inc three Corporate Drive Lake Zurich, IL 60047 |
Product Code | CAK |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SE) |
Type | 510(k) Traditio |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-06-23 |
Decision Date | 1995-02-28 |
NIH GUDID Devices
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