The following data is part of a premarket notification filed by Hemasure, Inc. with the FDA for Set, Transfer (blood/plasma).
| Device ID | BK950008 |
| 510k Number | BK950008 |
| Device Name: | Set, Transfer (Blood/Plasma) |
| Classification | Set, Transfer (blood/plasma) |
| Applicant | Hemasure, Inc. 140 Locke Drive Marlborough, MA 01752 |
| 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 | 1994-12-29 |
| Decision Date | 1995-06-28 |