The following data is part of a premarket notification filed by Megadyne Medical Products, Inc. with the FDA for Electrode Extender.
Device ID | K905060 |
510k Number | K905060 |
Device Name: | ELECTRODE EXTENDER |
Classification | Electrode, Electrosurgical |
Applicant | MEGADYNE MEDICAL PRODUCTS, INC. 6202 STRATLER ST. Murray, UT 84107 |
Contact | Matt Sansom |
Correspondent | Matt Sansom MEGADYNE MEDICAL PRODUCTS, INC. 6202 STRATLER ST. Murray, UT 84107 |
Product Code | JOS |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-11-08 |
Decision Date | 1991-04-12 |