The following data is part of a premarket notification filed by Dornier Medtech America, Inc. with the FDA for Gemini Lithotripter.
| Device ID | K121656 |
| 510k Number | K121656 |
| Device Name: | GEMINI LITHOTRIPTER |
| Classification | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Applicant | DORNIER MEDTECH AMERICA, INC. 1155 ROBERTS BLVD. Kennesaw, GA 30144 |
| Contact | John Hoffer |
| Correspondent | John Hoffer DORNIER MEDTECH AMERICA, INC. 1155 ROBERTS BLVD. Kennesaw, GA 30144 |
| Product Code | LNS |
| CFR Regulation Number | 876.5990 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-05 |
| Decision Date | 2012-09-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049957003265 | K121656 | 000 |
| 04049957003135 | K121656 | 000 |