LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS
FDA 510(k) clearance K033335 · decided 2003-11-25
Clearance details
- K-number
- K033335
- Device name
- LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS
- Applicant
- Siemens Medical Solutions USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-10-16
- Decision date
- 2003-11-25
- Days to decision
- 40 days
- Clearance type
- Special
- Product code
- MMZ
- Device class
- 2
- Regulation number
- 876.4890
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mavern, PA, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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