The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Stryker Ureteral Illumination System Iv.
| Device ID | K061548 |
| 510k Number | K061548 |
| Device Name: | STRYKER URETERAL ILLUMINATION SYSTEM IV |
| Classification | Light, Catheter, Fiberoptic, Glass, Ureteral |
| Applicant | STRYKER CORP. 5900 Optical Court San Jose, CA 95138 |
| Contact | Erica A Walters |
| Correspondent | Erica A Walters STRYKER CORP. 5900 Optical Court San Jose, CA 95138 |
| Product Code | FCS |
| CFR Regulation Number | 876.4020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-05 |
| Decision Date | 2006-09-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 37613327061216 | K061548 | 000 |