The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Silicone Double Coil Ureteral Stent With Suture.
Device ID | K862539 |
510k Number | K862539 |
Device Name: | SILICONE DOUBLE COIL URETERAL STENT WITH SUTURE |
Classification | Stent, Ureteral |
Applicant | MENTOR CORP. 600 PINE AVE. Goleta, CA 93117 |
Contact | Karen Edwards |
Correspondent | Karen Edwards 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 | 1986-07-02 |
Decision Date | 1986-09-09 |