The following data is part of a premarket notification filed by Wickimed Supply Limited with the FDA for Electrosurgical Pencil With Electrode, Wp200.
| Device ID | K100258 |
| 510k Number | K100258 |
| Device Name: | ELECTROSURGICAL PENCIL WITH ELECTRODE, WP200 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | WICKIMED SUPPLY LIMITED RM25, 11/F. 19 SHING YIP ST. KWUN TONG, KLN Hong Kong, CN |
| Contact | Kipson Fung |
| Correspondent | Kipson Fung WICKIMED SUPPLY LIMITED RM25, 11/F. 19 SHING YIP ST. KWUN TONG, KLN Hong Kong, CN |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-28 |
| Decision Date | 2010-04-28 |