The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Dyonics Vision 635 Image Management System.
| Device ID | K023053 |
| 510k Number | K023053 |
| Device Name: | DYONICS VISION 635 IMAGE MANAGEMENT SYSTEM |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | SMITH & NEPHEW, INC. 3600 NW 138TH ST. Oklahoma City, OK 73134 |
| Contact | Steven Jackson |
| Correspondent | Steven Jackson SMITH & NEPHEW, INC. 3600 NW 138TH ST. Oklahoma City, OK 73134 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-13 |
| Decision Date | 2002-10-03 |
| Summary: | summary |