The following data is part of a premarket notification filed by Northgate Research, Inc. with the FDA for 3f Electrode.
| Device ID | K864904 |
| 510k Number | K864904 |
| Device Name: | 3F ELECTRODE |
| Classification | Lithotriptor, Electro-hydraulic |
| Applicant | NORTHGATE RESEARCH, INC. FRANKLYN BUILDING RT. 9 NORTH, P.O. BOX 978 Plattsburgh, NY 12901 |
| Contact | James A Cochie |
| Correspondent | James A Cochie NORTHGATE RESEARCH, INC. FRANKLYN BUILDING RT. 9 NORTH, P.O. BOX 978 Plattsburgh, NY 12901 |
| Product Code | FFK |
| CFR Regulation Number | 876.4480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-15 |
| Decision Date | 1987-02-10 |