The following data is part of a premarket notification filed by Dornier Medtech America, Inc. with the FDA for Delta Iii Lithotripter.
| Device ID | K201074 |
| 510k Number | K201074 |
| Device Name: | Delta III Lithotripter |
| Classification | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Applicant | Dornier MedTech America, Inc. 1155 Roberts Blvd, Suite 100 Kennesaw, GA 30144 |
| Contact | John Hoffer |
| Correspondent | John Hoffer Dornier MedTech America, Inc. 1155 Roberts Blvd, Suite 100 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 | 2020-04-22 |
| Decision Date | 2020-09-03 |