The following data is part of a premarket notification filed by Fiberoptics Technology, Inc. with the FDA for F.t.i. Medical Light Guide.
| Device ID | K904378 |
| 510k Number | K904378 |
| Device Name: | F.T.I. MEDICAL LIGHT GUIDE |
| Classification | Source, Carrier, Fiberoptic Light |
| Applicant | FIBEROPTICS TECHNOLOGY, INC. 1 FIBER RD. Pomfret, CT 06258 |
| Contact | Allen Guillotte |
| Correspondent | Allen Guillotte FIBEROPTICS TECHNOLOGY, INC. 1 FIBER RD. Pomfret, CT 06258 |
| Product Code | EQH |
| CFR Regulation Number | 874.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-24 |
| Decision Date | 1991-01-16 |