The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Rhapsody H-30 Holmium Laser System.
| Device ID | K172325 |
| 510k Number | K172325 |
| Device Name: | Rhapsody H-30 Holmium Laser System |
| 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 | 2017-08-01 |
| Decision Date | 2017-10-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827002476257 | K172325 | 000 |