The following data is part of a premarket notification filed by Angiomed U.s., Inc. with the FDA for Angiomed Ureteral Stone Dislodgers.
| Device ID | K854652 |
| 510k Number | K854652 |
| Device Name: | ANGIOMED URETERAL STONE DISLODGERS |
| Classification | Dislodger, Stone, Basket, Ureteral, Metal |
| Applicant | ANGIOMED U.S., INC. 4081 EAST LA PALMA AVE., SUITE E Anaheim, CA 92807 |
| Contact | Richard Mohr |
| Correspondent | Richard Mohr ANGIOMED U.S., INC. 4081 EAST LA PALMA AVE., SUITE E Anaheim, CA 92807 |
| Product Code | FFL |
| CFR Regulation Number | 876.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-19 |
| Decision Date | 1986-02-10 |