The following data is part of a premarket notification filed by American Edwards Laboratories with the FDA for Ureteral Dilator & Ureteral Stone Dislodger.
| Device ID | K850954 |
| 510k Number | K850954 |
| Device Name: | URETERAL DILATOR & URETERAL STONE DISLODGER |
| Classification | Dislodger, Stone, Basket, Ureteral, Metal |
| Applicant | AMERICAN EDWARDS LABORATORIES P.O. BOX 11150 17221 RED HILL AVE.(IRVINE) Santa Ana, CA 92711 -1150 |
| Contact | Ronald J Ehmsen |
| Correspondent | Ronald J Ehmsen AMERICAN EDWARDS LABORATORIES P.O. BOX 11150 17221 RED HILL AVE.(IRVINE) Santa Ana, CA 92711 -1150 |
| Product Code | FFL |
| CFR Regulation Number | 876.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-08 |
| Decision Date | 1985-04-03 |