The following data is part of a premarket notification filed by Spembly Medical Ltd. with the FDA for Various Cardiac Cryoprobes Having Dia. & Cos. Diff.
| Device ID | K874367 |
| 510k Number | K874367 |
| Device Name: | VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF |
| Classification | Unit, Cautery, Thermal, Ac-powered |
| Applicant | SPEMBLY MEDICAL LTD. NEWBURY ROAD ANDOVER HAMPSHIRE SP10 4DR England, GB |
| Contact | Gordon Cook |
| Correspondent | Gordon Cook SPEMBLY MEDICAL LTD. NEWBURY ROAD ANDOVER HAMPSHIRE SP10 4DR England, GB |
| Product Code | HQO |
| CFR Regulation Number | 886.4115 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-23 |
| Decision Date | 1988-01-04 |