The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Mentor Black Light Injection Stent Set.
Device ID | K912060 |
510k Number | K912060 |
Device Name: | MENTOR BLACK LIGHT INJECTION STENT SET |
Classification | Stent, Ureteral |
Applicant | MENTOR CORP. 600 PINE AVE. Goleta, CA 93117 |
Contact | Byron H.wickett |
Correspondent | Byron H.wickett MENTOR CORP. 600 PINE AVE. Goleta, CA 93117 |
Product Code | FAD |
CFR Regulation Number | 876.4620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-05-09 |
Decision Date | 1991-09-27 |