The following data is part of a premarket notification filed by Spembly Medical Ltd. with the FDA for Cryomedics 5000 Cryosurgical Console.
| Device ID | K832334 |
| 510k Number | K832334 |
| Device Name: | CRYOMEDICS 5000 CRYOSURGICAL CONSOLE |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | SPEMBLY MEDICAL LTD. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-18 |
| Decision Date | 1983-08-12 |