The following data is part of a premarket notification filed by Cook, Inc. with the FDA for H-30 Holmium Laser System.
| Device ID | K130444 |
| 510k Number | K130444 |
| Device Name: | H-30 HOLMIUM LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | COOK, INC. 750 DANIELS WAY Bloomington, IN 47404 |
| Contact | Susanne Galin |
| Correspondent | Susanne Galin COOK, INC. 750 DANIELS WAY Bloomington, IN 47404 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-21 |
| Decision Date | 2013-05-22 |