The following data is part of a premarket notification filed by Dornier with the FDA for Dornier Lithotripter S(doli S) & Dornier Lithotripter S-xp (doli S-xp).
| Device ID | K011873 |
| 510k Number | K011873 |
| Device Name: | DORNIER LITHOTRIPTER S(DOLI S) & DORNIER LITHOTRIPTER S-XP (DOLI S-XP) |
| Classification | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Applicant | DORNIER 1155 ROBERTS BLVD. Kennesaw, GA 30144 |
| Contact | Suzannew Courtney |
| Correspondent | Suzannew Courtney DORNIER 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 | 2001-06-15 |
| Decision Date | 2001-08-31 |
| Summary: | summary |