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FDA 510(k), K050438, STEALTHSTATION SYSTEM UPDATE
FDA 510(k), K050438, STEALTHSTATION SYSTEM UPDATE
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510(K) Number: K050438
Device Name: STEALTHSTATION SYSTEM UPDATE
Manufacturer: MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES
Device Classification Name: neurological stereotaxic instrument
Regulation Number: 882.4560
Classification Product Code: HAW
Date Received: 02/22/2005
Decision Date: 06/02/2005
Regulation Medical Specialty: Neurology
Device Name: STEALTHSTATION SYSTEM UPDATE
Manufacturer: MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES
Device Classification Name: neurological stereotaxic instrument
Regulation Number: 882.4560
Classification Product Code: HAW
Date Received: 02/22/2005
Decision Date: 06/02/2005
Regulation Medical Specialty: Neurology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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