The following data is part of a premarket notification filed by Npbi with the FDA for Empty Containers For The Collection & Processing Of Blood/blood Components.
Device ID | BK960084 |
510k Number | BK960084 |
Device Name: | Empty Containers For The Collection & Processing Of Blood/Blood Components |
Classification | Container, Empty, For Collection & Processing Of Blood & Blood Components |
Applicant | NPBI runde Zz 41, 7881 Hm Emmer Compascuum Emmer-compascumm, NL |
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 | 1996-11-01 |
Decision Date | 1998-05-28 |