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FDA 510(k) Applications for Medical Device Product Code "HRN"
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FDA 510(k) Number | Applicant | Device Name | Decision Date |
K160591 | DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV | D.O.R.C. Disposable Cryo Probe | 01/23/2017 |
K012821 | DUTCH OPHTHALMIC USA, INC. | D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM | 10/22/2001 |
K062412 | KEELER INSTRUMENTS, INC. | CRYOMATIC | 11/06/2006 |
K112093 | KEELER INSTRUMENTS, INC. | CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER | 12/08/2011 |
K992954 | KEELER INSTRUMENTS, INC. | KEELER CRYO MASTER & PROBES | 12/21/1999 |
K131787 | KEELER LTD. | CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES | 12/23/2013 |
K180195 | Phakos | Frigitronics adapter | 03/16/2018 |
K200911 | Phakos | MIRA Adapter | 06/02/2020 |
K162756 | PHAKOS | PHAKOS Disposable Retinal Cryo Probe | 05/03/2017 |