The following data is part of a premarket notification filed by Dutch Ophthalmic Usa, Inc. with the FDA for D.o.r.c. Cryostar Cryosurgical System.
| Device ID | K012821 |
| 510k Number | K012821 |
| Device Name: | D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM |
| Classification | Unit, Cryophthalmic, Ac-powered |
| Applicant | DUTCH OPHTHALMIC USA, INC. ONE LITTLE RIVER RD. P.O. BOX 968 Kingston, NH 03848 |
| Contact | Mark W Furlong |
| Correspondent | Mark W Furlong DUTCH OPHTHALMIC USA, INC. ONE LITTLE RIVER RD. P.O. BOX 968 Kingston, NH 03848 |
| Product Code | HRN |
| CFR Regulation Number | 886.4170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-23 |
| Decision Date | 2001-10-22 |
| Summary: | summary |