The following data is part of a premarket notification filed by Rocket Of London, Ltd. with the FDA for Uriglow Transilluminating Ureteric Stent Model.
| Device ID | K943801 |
| 510k Number | K943801 |
| Device Name: | URIGLOW TRANSILLUMINATING URETERIC STENT MODEL |
| Classification | Light, Catheter, Fiberoptic, Glass, Ureteral |
| Applicant | ROCKET OF LONDON, LTD. WEAR INDUSTRIAL ESTATE WASHINGTON Tyne & Wear, GB Ne37 1ne |
| Contact | Richard Keen |
| Correspondent | Richard Keen ROCKET OF LONDON, LTD. WEAR INDUSTRIAL ESTATE WASHINGTON Tyne & Wear, GB Ne37 1ne |
| Product Code | FCS |
| CFR Regulation Number | 876.4020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-03 |
| Decision Date | 1995-08-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055270943125 | K943801 | 000 |