The following data is part of a premarket notification filed by Diomedics, Inc. with the FDA for Diomedics Surgi Light/light Touch Optical Fibers.
Device ID | K926224 |
510k Number | K926224 |
Device Name: | DIOMEDICS SURGI LIGHT/LIGHT TOUCH OPTICAL FIBERS |
Classification | Powered Laser Surgical Instrument |
Applicant | DIOMEDICS, INC. 2828 N. CRESCENT DR. The Woodlands, TX 77381 |
Contact | Krista Oakes |
Correspondent | Krista Oakes DIOMEDICS, INC. 2828 N. CRESCENT DR. The Woodlands, TX 77381 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-10 |
Decision Date | 1993-07-22 |