The following data is part of a premarket notification filed by Medisurg Ltd. with the FDA for The Fugo Blade For Dentistry.
| Device ID | K063468 |
| 510k Number | K063468 |
| Device Name: | THE FUGO BLADE FOR DENTISTRY |
| Classification | Unit, Electrosurgical, And Accessories, Dental |
| Applicant | MEDISURG LTD. 100 WEST FORNANCE ST. THE FUGO BUILDING Norristown, PA 19401 |
| Contact | Richard J Fugo |
| Correspondent | Richard J Fugo MEDISURG LTD. 100 WEST FORNANCE ST. THE FUGO BUILDING Norristown, PA 19401 |
| Product Code | EKZ |
| CFR Regulation Number | 872.4920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-16 |
| Decision Date | 2007-04-18 |
| Summary: | summary |