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 |