The following data is part of a premarket notification filed by Spembly Medical Ltd. with the FDA for Cryoprobes Mc-1400-cryosurg-console.
| Device ID | K832385 |
| 510k Number | K832385 |
| Device Name: | CRYOPROBES MC-1400-CRYOSURG-CONSOLE |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | SPEMBLY MEDICAL LTD. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-19 |
| Decision Date | 1983-09-12 |