The following data is part of a premarket notification filed by Monaghan Medical Corp. with the FDA for Lithotriptor Electrode 4.5f.
| Device ID | K834228 |
| 510k Number | K834228 |
| Device Name: | LITHOTRIPTOR ELECTRODE 4.5F |
| Classification | Lithotriptor, Electro-hydraulic |
| Applicant | MONAGHAN MEDICAL CORP. FRANKLYN BLDG RT. 9 NORTH P.O. BOX 978 Plattsburgh, NY 12901 |
| Contact | William R Shene |
| Correspondent | William R Shene MONAGHAN MEDICAL CORP. FRANKLYN BLDG 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 | 1983-12-06 |
| Decision Date | 1984-05-25 |