The following data is part of a premarket notification filed by Spembly Medical Ltd. with the FDA for Spembly Medical 242 Cryounit/series 242 Cryoprobes.
| Device ID | K903303 |
| 510k Number | K903303 |
| Device Name: | SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES |
| Classification | Unit, Cryophthalmic |
| Applicant | SPEMBLY MEDICAL LTD. NEWBURY ROAD ANDOVER HAMPSHIRE SP10 4DR England, GB |
| Contact | R. B Coleman |
| Correspondent | R. B Coleman SPEMBLY MEDICAL LTD. NEWBURY ROAD ANDOVER HAMPSHIRE SP10 4DR England, GB |
| Product Code | HPS |
| CFR Regulation Number | 886.4170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-24 |
| Decision Date | 1990-10-11 |