The following data is part of a premarket notification filed by Dornier Medtech America with the FDA for Gemini Xxp-hp.
| Device ID | K151298 |
| 510k Number | K151298 |
| Device Name: | Gemini XXP-HP |
| Classification | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Applicant | Dornier MedTech America 1155 Roberts Blvd Kennesaw, GA 30144 |
| Contact | John Hoffer |
| Correspondent | John Hoffer Dornier MedTech America 1155 Roberts Blvd Kennesaw, GA 30144 |
| Product Code | LNS |
| CFR Regulation Number | 876.5990 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-15 |
| Decision Date | 2015-07-30 |
| Summary: | summary |