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 |