The following data is part of a premarket notification filed by Medsep Corporation with the FDA for Empty Containers For The Collection & Processing Of Blood/blood Components.
Device ID | BK980027 |
510k Number | BK980027 |
Device Name: | Empty Containers For The Collection & Processing Of Blood/Blood Components |
Classification | Container, Empty, For Collection & Processing Of Blood & Blood Components |
Applicant | MEDSEP Corporation 330 Turnbull Canyon Road City Of Industry, CA 91745 US |
Product Code | KSR |
CFR Regulation Number | 864.9100 [🔎] |
Decision | Substantially Equivalent (SE) |
Type | 510(k) Traditio |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-08-03 |
Decision Date | 1999-03-26 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
30636207302442 | BK980027 | 0 |