The following data is part of a premarket notification filed by Medsep Corporation with the FDA for Blood Transfusion Microfilters.
| Device ID | BK910019 |
| 510k Number | BK910019 |
| Device Name: | Blood Transfusion Microfilters |
| Classification | Microfilter, Blood Transfusion |
| Applicant | Medsep Corporation 2200 Northern Boulevard East Hills, NY 11548 |
| 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 | 1991-08-08 |
| Decision Date | 1992-01-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10887691313940 | BK910019 | 0 |
| 30887691305796 | BK910019 | 0 |
| 30887691305307 | BK910019 | 0 |
| 30887691304218 | BK910019 | 0 |
| 30887691000752 | BK910019 | 0 |
| 30887691000707 | BK910019 | 0 |
| 30887691000431 | BK910019 | 0 |