The following data is part of a premarket notification filed by United Medical Systems, Inc. with the FDA for Piezolith 3000 Lithotripter, Model 3000.
| Device ID | K032958 |
| 510k Number | K032958 |
| Device Name: | PIEZOLITH 3000 LITHOTRIPTER, MODEL 3000 |
| Classification | Lithotriptor, Extracorporeal Shock-wave, Urological |
| Applicant | UNITED MEDICAL SYSTEMS, INC. 555 THIRTEENTH STREET, NW Washington, DC 20004 -1109 |
| Contact | Jeffrey K Shapiro |
| Correspondent | Jeffrey K Shapiro UNITED MEDICAL SYSTEMS, INC. 555 THIRTEENTH STREET, NW Washington, DC 20004 -1109 |
| Product Code | LNS |
| CFR Regulation Number | 876.5990 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-22 |
| Decision Date | 2004-02-17 |
| Summary: | summary |