The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Light Guide.
| Device ID | K993314 |
| 510k Number | K993314 |
| Device Name: | SYNTHES LIGHT GUIDE |
| Classification | Lamp, Operating-room |
| Applicant | SYNTHES (USA) 1303 GOSHEN PKWY. Wast Chester, PA 19380 |
| Contact | Jonathan Gilbert |
| Correspondent | Jonathan Gilbert SYNTHES (USA) 1303 GOSHEN PKWY. Wast Chester, PA 19380 |
| Product Code | FQP |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-04 |
| Decision Date | 1999-12-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07611819099548 | K993314 | 000 |
| 07611819109230 | K993314 | 000 |
| 07611819098930 | K993314 | 000 |
| 07611819098947 | K993314 | 000 |
| 07611819098954 | K993314 | 000 |
| 07611819098985 | K993314 | 000 |
| 07611819103375 | K993314 | 000 |
| 07611819099524 | K993314 | 000 |
| 07611819583894 | K993314 | 000 |
| 07611819099487 | K993314 | 000 |
| 07611819099494 | K993314 | 000 |
| 07611819099500 | K993314 | 000 |
| 07611819099517 | K993314 | 000 |
| 07611819099531 | K993314 | 000 |
| 07611819109223 | K993314 | 000 |