The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Cook Holmium Laser Fiber.
| Device ID | K163197 |
| 510k Number | K163197 |
| Device Name: | Cook Holmium Laser Fiber |
| Classification | Powered Laser Surgical Instrument |
| Applicant | COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489 Bloomington, IN 47402 |
| Contact | Colin Jacob |
| Correspondent | Colin Jacob COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489 Bloomington, IN 47402 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-15 |
| Decision Date | 2017-05-24 |
| Summary: | summary |