The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Cds System.
| Device ID | K051136 |
| 510k Number | K051136 |
| Device Name: | SMITH & NEPHEW CDS SYSTEM |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | SMITH & NEPHEW, INC. 150 MINUTEMAN RD. Andover, MA 01810 |
| Contact | Diane E Minear |
| Correspondent | Diane E Minear SMITH & NEPHEW, INC. 150 MINUTEMAN RD. Andover, MA 01810 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-04 |
| Decision Date | 2005-07-01 |
| Summary: | summary |