The following data is part of a premarket notification filed by Cryosan Inc. with the FDA for System, Processing For Frozen Blood.
| Device ID | BK820021 |
| 510k Number | BK820021 |
| Device Name: | System, Processing For Frozen Blood |
| Classification | System, Processing For Frozen Blood |
| Applicant | Cryosan Inc. 850 Providence Highway Dedham, MA 02026 |
| Product Code | KSW |
| CFR Regulation Number | 864.9145 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-11-29 |
| Decision Date | 1983-01-03 |