STEALTHSTATION SYSTEM UPDATE
FDA 510(k) clearance K050438 · decided 2005-06-02
Clearance details
- K-number
- K050438
- Device name
- STEALTHSTATION SYSTEM UPDATE
- Applicant
- Medtronic Surgical Navigation Technologies
- Decision
- Substantially Equivalent
- Date received
- 2005-02-22
- Decision date
- 2005-06-02
- Days to decision
- 100 days
- Clearance type
- Special
- Product code
- HAW
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Louisville, CO, US
- Third-party review
- No
- Expedited review
- No
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