The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard Inlayoptima Ureteral Stent With Suture.
| Device ID | K043193 |
| 510k Number | K043193 |
| Device Name: | BARD INLAYOPTIMA URETERAL STENT WITH SUTURE |
| Classification | Stent, Ureteral |
| Applicant | C.R. BARD, INC. 8195 INDUSTRIAL BLVD Covington, GA 30014 |
| Contact | Frances E Harrison |
| Correspondent | Frances E Harrison C.R. BARD, INC. 8195 INDUSTRIAL BLVD Covington, GA 30014 |
| Product Code | FAD |
| CFR Regulation Number | 876.4620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-18 |
| Decision Date | 2004-12-07 |
| Summary: | summary |