The following data is part of a premarket notification filed by Keeler Ltd. with the FDA for Cryomatic Mkii Console, Cryomatic Mkii Probes, Disposable Cryo Probes.
| Device ID | K131787 |
| 510k Number | K131787 |
| Device Name: | CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES |
| Classification | Unit, Cryophthalmic, Ac-powered |
| Applicant | KEELER LTD. 456 PARKWAY Broomall, PA 19008 |
| Contact | Eugene R Vanarsdale |
| Correspondent | Eugene R Vanarsdale KEELER LTD. 456 PARKWAY 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 | 2013-06-18 |
| Decision Date | 2013-12-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055272711869 | K131787 | 000 |
| 05055272711852 | K131787 | 000 |
| 05055272711845 | K131787 | 000 |
| 05055272711838 | K131787 | 000 |
| 05055272711821 | K131787 | 000 |
| 05055272711814 | K131787 | 000 |
| 05055272711760 | K131787 | 000 |
| 05055272711753 | K131787 | 000 |