The following data is part of a premarket notification filed by Monaghan Medical Corp. with the FDA for 4.5 F Lithotriptor Electrode.
| Device ID | K830086 |
| 510k Number | K830086 |
| Device Name: | 4.5 F LITHOTRIPTOR ELECTRODE |
| Classification | Lithotriptor, Electro-hydraulic |
| Applicant | MONAGHAN MEDICAL CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FFK |
| CFR Regulation Number | 876.4480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-01-11 |
| Decision Date | 1983-02-09 |