The following data is part of a premarket notification filed by Northgate Research, Inc. with the FDA for Model Sd-1 Disintegrator.
| Device ID | K802322 |
| 510k Number | K802322 |
| Device Name: | MODEL SD-1 DISINTEGRATOR |
| Classification | Lithotriptor, Electro-hydraulic |
| Applicant | NORTHGATE RESEARCH, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FFK |
| CFR Regulation Number | 876.4480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-09-23 |
| Decision Date | 1980-11-10 |