The following data is part of a premarket notification filed by Stryker Endoscopy with the FDA for Stryker Ureteral Illuminator System Iii.
| Device ID | K982542 |
| 510k Number | K982542 |
| Device Name: | STRYKER URETERAL ILLUMINATOR SYSTEM III |
| Classification | Light, Catheter, Fiberoptic, Glass, Ureteral |
| Applicant | Stryker Endoscopy 2590 WALSH AVE. Santa Clara, CA 95051 -4085 |
| Contact | Tony Lee |
| Correspondent | Tony Lee Stryker Endoscopy 2590 WALSH AVE. Santa Clara, CA 95051 -4085 |
| Product Code | FCS |
| CFR Regulation Number | 876.4020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-21 |
| Decision Date | 1998-09-22 |
| Summary: | summary |