The following data is part of a premarket notification filed by Technology Delivery Systems, Inc. with the FDA for Maxiflex Fiber Optic Energy Delivery System.
| Device ID | K013300 |
| 510k Number | K013300 |
| Device Name: | MAXIFLEX FIBER OPTIC ENERGY DELIVERY SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | TECHNOLOGY DELIVERY SYSTEMS, INC. 200 GREGORY LANE, STE C-100 Pleasant Hill, CA 94523 -3389 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf TECHNOLOGY DELIVERY SYSTEMS, INC. 200 GREGORY LANE, STE C-100 Pleasant Hill, CA 94523 -3389 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-03 |
| Decision Date | 2002-04-16 |
| Summary: | summary |