The following data is part of a premarket notification filed by Angiomed U.s., Inc. with the FDA for Angiomed Ureteral D&m Sets/ureteroscopy Guid Stent.
| Device ID | K864225 |
| 510k Number | K864225 |
| Device Name: | ANGIOMED URETERAL D&M SETS/URETEROSCOPY GUID STENT |
| Classification | Stent, Ureteral |
| Applicant | ANGIOMED U.S., INC. 4081 EAST LA PALMA AVE., SUITE E Anaheim, CA 92807 |
| Contact | Richard P Mohr |
| Correspondent | Richard P Mohr ANGIOMED U.S., INC. 4081 EAST LA PALMA AVE., SUITE E Anaheim, CA 92807 |
| Product Code | FAD |
| CFR Regulation Number | 876.4620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-28 |
| Decision Date | 1987-01-30 |