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 |