The following data is part of a premarket notification filed by Spembly Medical Ltd. with the FDA for Cryomedics Neurostat.
| Device ID | K831963 |
| 510k Number | K831963 |
| Device Name: | CRYOMEDICS NEUROSTAT |
| Classification | Device, Surgical, Cryogenic |
| Applicant | SPEMBLY MEDICAL LTD. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GXH |
| CFR Regulation Number | 882.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-06-17 |
| Decision Date | 1983-08-12 |