The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Mentor Unistent Ureteral Stent Set.
Device ID | K875038 |
510k Number | K875038 |
Device Name: | MENTOR UNISTENT URETERAL STENT SET |
Classification | Stent, Ureteral |
Applicant | MENTOR CORP. 600 PINE AVE. Goleta, CA 93117 |
Contact | R Breckenridge |
Correspondent | R Breckenridge 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 | 1987-12-07 |
Decision Date | 1988-03-03 |