The following data is part of a premarket notification filed by Debusk Technology Corp. with the FDA for Electrosurgical Monopolar Handswitching Pencil W/removable Blade.
| Device ID | K940909 |
| 510k Number | K940909 |
| Device Name: | ELECTROSURGICAL MONOPOLAR HANDSWITCHING PENCIL W/REMOVABLE BLADE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | DEBUSK TECHNOLOGY CORP. 200 DEBUSK LN. Powell, TN 37849 |
| Contact | Debra F Manning |
| Correspondent | Debra F Manning DEBUSK TECHNOLOGY CORP. 200 DEBUSK LN. Powell, TN 37849 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-23 |
| Decision Date | 1994-03-30 |