The following data is part of a premarket notification filed by Conmed Corp. with the FDA for Tech-switch Electrosurgical Pencil, Single Use.
Device ID | K932345 |
510k Number | K932345 |
Device Name: | TECH-SWITCH ELECTROSURGICAL PENCIL, SINGLE USE |
Classification | Electrosurgical Device |
Applicant | CONMED CORP. 310 BROAD ST. Utica, NY 13501 -1203 |
Contact | Martin Forte |
Correspondent | Martin Forte CONMED CORP. 310 BROAD ST. Utica, NY 13501 -1203 |
Product Code | DWG |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-14 |
Decision Date | 1994-04-12 |