The following data is part of a premarket notification filed by Dornier with the FDA for Dornier Lithotripter 140(doli 140).
| Device ID | K011773 |
| 510k Number | K011773 |
| Device Name: | DORNIER LITHOTRIPTER 140(DOLI 140) |
| Classification | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Applicant | DORNIER 1155 ROBERTS BLVD. Kennesaw, GA 30144 |
| Contact | Suzanne Courtney |
| Correspondent | Suzanne Courtney DORNIER 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 | 2001-06-07 |
| Decision Date | 2001-06-22 |
| Summary: | summary |