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 |