The following data is part of a premarket notification filed by Northgate Research, Inc. with the FDA for Urological Stone Basket.
| Device ID | K891254 |
| 510k Number | K891254 |
| Device Name: | UROLOGICAL STONE BASKET |
| Classification | Dislodger, Stone, Basket, Ureteral, Metal |
| Applicant | NORTHGATE RESEARCH, INC. 3930 VENTURA DR. SUITE 400 Arlington Heights, IL 60004 |
| Contact | Charles P Gill |
| Correspondent | Charles P Gill NORTHGATE RESEARCH, INC. 3930 VENTURA DR. SUITE 400 Arlington Heights, IL 60004 |
| Product Code | FFL |
| CFR Regulation Number | 876.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-08 |
| Decision Date | 1989-03-22 |