The following data is part of a premarket notification filed by Cryosan, Inc. with the FDA for Circulating Cyto-therms.
| Device ID | K812311 |
| 510k Number | K812311 |
| Device Name: | CIRCULATING CYTO-THERMS |
| Classification | Device, Warming. Blood And Plasma |
| Applicant | CRYOSAN, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KZL |
| CFR Regulation Number | 864.9205 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-08-17 |
| Decision Date | 1981-09-16 |