The following data is part of a premarket notification filed by Fibertech Gmbh with the FDA for Ft Fiber Optic Delivery Systems.
| Device ID | K050738 | 
| 510k Number | K050738 | 
| Device Name: | FT FIBER OPTIC DELIVERY SYSTEMS | 
| Classification | Powered Laser Surgical Instrument | 
| Applicant | FIBERTECH GMBH 4111 E. VALLEY AUTO DRIVE SUITE 104 Mesa, AZ 85206 | 
| Contact | Armin Kaus | 
| Correspondent | Armin Kaus FIBERTECH GMBH 4111 E. VALLEY AUTO DRIVE SUITE 104 Mesa, AZ 85206 | 
| Product Code | GEX | 
| CFR Regulation Number | 878.4810 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 2005-03-17 | 
| Decision Date | 2005-06-02 | 
| Summary: | summary |