The following data is part of a premarket notification filed by Northgate Technologies, Inc. with the FDA for Electro Mechanical Lithotriptor.
| Device ID | K990341 |
| 510k Number | K990341 |
| Device Name: | ELECTRO MECHANICAL LITHOTRIPTOR |
| Classification | Lithotriptor, Electro-hydraulic |
| Applicant | NORTHGATE TECHNOLOGIES, INC. 600 CHURCH RD. Elgin, IL 60123 |
| Contact | Cassy Kurek |
| Correspondent | Cassy Kurek NORTHGATE TECHNOLOGIES, INC. 600 CHURCH RD. Elgin, IL 60123 |
| Product Code | FFK |
| CFR Regulation Number | 876.4480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-03 |
| Decision Date | 1999-07-14 |
| Summary: | summary |