The following data is part of a premarket notification filed by Ureteral Stent Company with the FDA for Relief Ureteral Stent Kit; Model: Rs-001 - 6 Fr X 24cm, Relief Ureteral Stent Kit; Model: Rs-002 - 6 Fr X 26cm.
Device ID | K213444 |
510k Number | K213444 |
Device Name: | RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr X 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr X 26cm |
Classification | Stent, Ureteral |
Applicant | Ureteral Stent Company 45 Glenridge Court Chagrin Falls, OH 44022 |
Contact | Mike Bunker |
Correspondent | Mike Bunker Ureteral Stent Company 45 Glenridge Court Chagrin Falls, OH 44022 |
Product Code | FAD |
CFR Regulation Number | 876.4620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-10-25 |
Decision Date | 2022-03-17 |