The following data is part of a premarket notification filed by Conmed Corp. with the FDA for Electrosurgical And Arthroscopy Accessory Electrodes.
Device ID | K961812 |
510k Number | K961812 |
Device Name: | ELECTROSURGICAL AND ARTHROSCOPY ACCESSORY ELECTRODES |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | CONMED CORP. P.O. BOX 1408 Dayton, OH 45401 -1408 |
Contact | Ira D Duesler, Jr. |
Correspondent | Ira D Duesler, Jr. CONMED CORP. P.O. BOX 1408 Dayton, OH 45401 -1408 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-05-10 |
Decision Date | 1996-06-13 |