The following data is part of a premarket notification filed by Henley Intl. with the FDA for Cryotron-ul30.
| Device ID | K900419 |
| 510k Number | K900419 |
| Device Name: | CRYOTRON-UL30 |
| Classification | Unit, Chilling |
| Applicant | HENLEY INTL. 104 INDUSTRIAL BLVD., Sugar Land, TX 77470 |
| Contact | Ernest J Henley,phd |
| Correspondent | Ernest J Henley,phd HENLEY INTL. 104 INDUSTRIAL BLVD., Sugar Land, TX 77470 |
| Product Code | IMF |
| CFR Regulation Number | 890.5940 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-30 |
| Decision Date | 1990-02-27 |