The following data is part of a premarket notification filed by Dornier Medtech America with the FDA for Extra Corporeal Shockwave Lithotripter.
| Device ID | K132672 |
| 510k Number | K132672 |
| Device Name: | EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-27 |
| Decision Date | 2013-09-23 |
| Summary: | summary |