The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Lithostar Modularis With Shockwave System Cplus.
| Device ID | K033335 |
| 510k Number | K033335 |
| Device Name: | LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS |
| Classification | Table, Cystometric, Electric |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406 |
| Contact | Debbie Peacock |
| Correspondent | Debbie Peacock SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406 |
| Product Code | MMZ |
| CFR Regulation Number | 876.4890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-16 |
| Decision Date | 2003-11-25 |
| Summary: | summary |