The following data is part of a premarket notification filed by Cobe Cardiovascular, Inc. with the FDA for Automated Blood Cell Separators.
Device ID | BK970023 |
510k Number | BK970023 |
Device Name: | Automated Blood Cell Separators |
Classification | Separator, Automated, Blood Cell, Diagnostic |
Applicant | COBE Cardiovascular, Inc. 1201 Oak Street Lakewood, CO 80215 |
Product Code | GKT |
CFR Regulation Number | 864.9245 [🔎] |
Decision | Substantially Equivalent (SE) |
Type | 510(k) Traditio |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-07-16 |
Decision Date | 1998-10-13 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05020583810020 | BK970023 | 0 |
05020583810013 | BK970023 | 0 |
05020583810006 | BK970023 | 0 |