The following data is part of a premarket notification filed by Northgate Research, Inc. with the FDA for 2.5 French Lithotriptor Electrode.
| Device ID | K894704 |
| 510k Number | K894704 |
| Device Name: | 2.5 FRENCH LITHOTRIPTOR ELECTRODE |
| Classification | Lithotriptor, Electro-hydraulic |
| Applicant | NORTHGATE RESEARCH, INC. 3930 VENTURA DR. SUITE 400 Arlington Heights, IL 60004 |
| Contact | D Emrich |
| Correspondent | D Emrich NORTHGATE RESEARCH, INC. 3930 VENTURA DR. SUITE 400 Arlington Heights, IL 60004 |
| Product Code | FFK |
| CFR Regulation Number | 876.4480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-25 |
| Decision Date | 1989-10-18 |