The following data is part of a premarket notification filed by Lake Region Mfg., Inc. with the FDA for Duthoy Stone Basket.
| Device ID | K861469 |
| 510k Number | K861469 |
| Device Name: | DUTHOY STONE BASKET |
| Classification | Dislodger, Stone, Basket, Ureteral, Metal |
| Applicant | LAKE REGION MFG., INC. 340 LAKE HAZELTINE DR. Chaska, MN 55318 |
| Contact | Jim Klosterman |
| Correspondent | Jim Klosterman LAKE REGION MFG., INC. 340 LAKE HAZELTINE DR. Chaska, MN 55318 |
| Product Code | FFL |
| CFR Regulation Number | 876.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-22 |
| Decision Date | 1986-05-15 |