The following data is part of a premarket notification filed by Ethox Corp. with the FDA for Empty Containers For The Collection & Processing Of Blood/blood Components.
Device ID | BK920002 |
510k Number | BK920002 |
Device Name: | Empty Containers For The Collection & Processing Of Blood/Blood Components |
Classification | Container, Empty, For Collection & Processing Of Blood & Blood Components |
Applicant | Ethox Corp. 251 Seneca St, Buffalo, NY 14204 |
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 | 1992-01-06 |
Decision Date | 1992-09-17 |