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 |