The following data is part of a premarket notification filed by Terumo Medical Corporation with the FDA for Transfer Sets.
| Device ID | BK970008 |
| 510k Number | BK970008 |
| Device Name: | Transfer Sets |
| Classification | Set, Transfer (blood/plasma) |
| Applicant | Terumo Medical Corporation 125 Blue Ball Road Elkton, MD 21921 |
| Product Code | KSB |
| CFR Regulation Number | 864.9875 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-15 |
| Decision Date | 1998-05-28 |