The following data is part of a premarket notification filed by Spembly Medical Ltd. with the FDA for Spembly Medical 142 Cryo Unit.
| Device ID | K882963 |
| 510k Number | K882963 |
| Device Name: | SPEMBLY MEDICAL 142 CRYO UNIT |
| Classification | Unit, Cryosurgical, Accessories |
| 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 | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-14 |
| Decision Date | 1988-08-08 |