The following data is part of a premarket notification filed by Dutch Ophthalmic Usa, Inc. with the FDA for Ophthalmic Cryo Unit.
| Device ID | K940373 |
| 510k Number | K940373 |
| Device Name: | OPHTHALMIC CRYO UNIT |
| Classification | Unit, Cryophthalmic |
| Applicant | DUTCH OPHTHALMIC USA, INC. TEN MARSHALL RD. P.O. BOX 968 Kingston, NH 03848 |
| Contact | Mark W Furlong |
| Correspondent | Mark W Furlong DUTCH OPHTHALMIC USA, INC. TEN MARSHALL RD. P.O. BOX 968 Kingston, NH 03848 |
| Product Code | HPS |
| CFR Regulation Number | 886.4170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-26 |
| Decision Date | 1994-07-18 |