The following data is part of a premarket notification filed by Conmed Corp. with the FDA for Electrosurgical Dispersive Electrode.
Device ID | K983782 |
510k Number | K983782 |
Device Name: | ELECTROSURGICAL DISPERSIVE ELECTRODE |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | CONMED CORP. 310 BROAD ST. Utica, NY 13501 -1203 |
Contact | Ira D Duesler, Jr |
Correspondent | Ira D Duesler, Jr CONMED CORP. 310 BROAD ST. Utica, NY 13501 -1203 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-10-27 |
Decision Date | 1999-01-25 |