The following data is part of a premarket notification filed by Northgate Technologies, Inc. with the FDA for Sd-200iehl(tm).
| Device ID | K914517 |
| 510k Number | K914517 |
| Device Name: | SD-200IEHL(TM) |
| Classification | Lithotriptor, Electro-hydraulic |
| Applicant | NORTHGATE TECHNOLOGIES, INC. 3930 VENTURA DR. Arlington Heights, IL 60004 |
| Contact | Scott K Gilchrist |
| Correspondent | Scott K Gilchrist NORTHGATE TECHNOLOGIES, INC. 3930 VENTURA DR. 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 | 1991-10-09 |
| Decision Date | 1992-06-30 |