The following data is part of a premarket notification filed by Keeler Instruments, Inc. with the FDA for Cryomatic Cryo Console, Disposable Cryo Probe, Disposable Probe Adapter.
| Device ID | K112093 |
| 510k Number | K112093 |
| Device Name: | CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER |
| Classification | Unit, Cryophthalmic, Ac-powered |
| Applicant | KEELER INSTRUMENTS, INC. 456 PKWY. Broomall, PA 19008 |
| Contact | Eugene R Vanarsdale |
| Correspondent | Eugene R Vanarsdale KEELER INSTRUMENTS, INC. 456 PKWY. Broomall, PA 19008 |
| Product Code | HRN |
| CFR Regulation Number | 886.4170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-22 |
| Decision Date | 2011-12-08 |