The following data is part of a premarket notification filed by Cuda Products Co. with the FDA for Fiber Optic Light Guide Or Fiber Optic Cable.
| Device ID | K901035 |
| 510k Number | K901035 |
| Device Name: | FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLE |
| Classification | Light, Surgical, Fiberoptic |
| Applicant | CUDA PRODUCTS CO. 6000 POWERS AVE. Jacksonville, FL 32217 |
| Contact | Cynthia Arcusa |
| Correspondent | Cynthia Arcusa CUDA PRODUCTS CO. 6000 POWERS AVE. Jacksonville, FL 32217 |
| Product Code | FST |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-06 |
| Decision Date | 1990-04-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00191375010081 | K901035 | 000 |
| 10886705028825 | K901035 | 000 |
| 10886705028818 | K901035 | 000 |
| 10885403155291 | K901035 | 000 |
| 10885403155284 | K901035 | 000 |
| 10885403155277 | K901035 | 000 |
| 10885403155260 | K901035 | 000 |
| 10885403155253 | K901035 | 000 |
| 10885403155215 | K901035 | 000 |
| 10885403155208 | K901035 | 000 |
| 10885403155185 | K901035 | 000 |
| 10885403155178 | K901035 | 000 |
| 10885403155161 | K901035 | 000 |
| 10885403155154 | K901035 | 000 |
| 00888867100671 | K901035 | 000 |
| M678FOC0 | K901035 | 000 |
| M678HLC0 | K901035 | 000 |
| 10886705028832 | K901035 | 000 |
| 10886705028849 | K901035 | 000 |
| 00191375010074 | K901035 | 000 |
| 00191375010067 | K901035 | 000 |
| 20845854040420 | K901035 | 000 |
| 30845854040373 | K901035 | 000 |
| 30845854027435 | K901035 | 000 |
| 30845854024830 | K901035 | 000 |
| 10705034225173 | K901035 | 000 |
| 10705034220734 | K901035 | 000 |
| 10705034217789 | K901035 | 000 |
| 10705034217727 | K901035 | 000 |
| 00888867029408 | K901035 | 000 |
| 00888867029415 | K901035 | 000 |
| 00888867029392 | K901035 | 000 |
| 00888867350946 | K901035 | 000 |
| 10886705028863 | K901035 | 000 |
| 10886705028856 | K901035 | 000 |
| 00888867353244 | K901035 | 000 |