The following data is part of a premarket notification filed by Medisurg Ltd. with the FDA for Fugo Blade For Peripheral Iridotomy, Model M300.
| Device ID | K050933 |
| 510k Number | K050933 |
| Device Name: | FUGO BLADE FOR PERIPHERAL IRIDOTOMY, MODEL M300 |
| Classification | Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-powered |
| 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 | NCR |
| CFR Regulation Number | 886.4100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-14 |
| Decision Date | 2005-12-09 |
| Summary: | summary |