The following data is part of a premarket notification filed by Dutch Ophthalmic Research Center International Bv with the FDA for D.o.r.c. Disposable Cryo Probe.
| Device ID | K160591 |
| 510k Number | K160591 |
| Device Name: | D.O.R.C. Disposable Cryo Probe |
| Classification | Unit, Cryophthalmic, Ac-powered |
| Applicant | DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV SCHEIJDELVEWEG 2 Zuidland, NL 3214 Vn |
| Contact | Danielle Sleegers |
| Correspondent | Danielle Sleegers DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV SCHEIJDELVEWEG 2 Zuidland, NL 3214 Vn |
| Product Code | HRN |
| CFR Regulation Number | 886.4170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-01 |
| Decision Date | 2017-01-23 |
| Summary: | summary |