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 |