The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Images Cystourethroscopes And Accessories, Smith & Nephew Semi0rigid And Flexible Manual Surgical Instrum.
| Device ID | K972979 |
| 510k Number | K972979 |
| Device Name: | SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RIGID AND FLEXIBLE MANUAL SURGICAL INSTRUM |
| Classification | Cystourethroscope |
| Applicant | SMITH & NEPHEW, INC. 160 DASCOMB RD. Andover, MA 01810 |
| Contact | Deborah J Connors |
| Correspondent | Deborah J Connors SMITH & NEPHEW, INC. 160 DASCOMB RD. Andover, MA 01810 |
| Product Code | FBO |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-11 |
| Decision Date | 1997-12-11 |
| Summary: | summary |