The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Subcutaneous Illuminator.
| Device ID | K991323 |
| 510k Number | K991323 |
| Device Name: | SMITH & NEPHEW SUBCUTANEOUS ILLUMINATOR |
| Classification | Image, Illumination, Fiberoptic, For Endoscope |
| Applicant | SMITH & NEPHEW, INC. 160 DASCOMB RD. Andover, MA 01810 |
| Contact | Deborah Connors |
| Correspondent | Deborah Connors SMITH & NEPHEW, INC. 160 DASCOMB RD. Andover, MA 01810 |
| Product Code | FFS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-19 |
| Decision Date | 1999-07-06 |
| Summary: | summary |