The following data is part of a premarket notification filed by Cryomedical Instruments, Ltd. with the FDA for Cryomedical Instruments Cryo-pac Systems.
| Device ID | K050272 |
| 510k Number | K050272 |
| Device Name: | CRYOMEDICAL INSTRUMENTS CRYO-PAC SYSTEMS |
| Classification | Device, Surgical, Cryogenic |
| Applicant | CRYOMEDICAL INSTRUMENTS, LTD. GROVE WAY MANSFIELD WOODHOUSE Mansfield, GB Ng19 8bw |
| Contact | Gareth Copping |
| Correspondent | Gareth Copping CRYOMEDICAL INSTRUMENTS, LTD. GROVE WAY MANSFIELD WOODHOUSE Mansfield, GB Ng19 8bw |
| Product Code | GXH |
| CFR Regulation Number | 882.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-04 |
| Decision Date | 2005-03-24 |
| Summary: | summary |