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FDA 510(k), K092239, ROSA SURGICAL DEVICE, MODEL ROSA 1.1
FDA 510(k), K092239, ROSA SURGICAL DEVICE, MODEL ROSA 1.1
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510(K) Number: K092239
Device Name: ROSA SURGICAL DEVICE, MODEL ROSA 1.1
Manufacturer: MEDTECH S.A.
Device Classification Name: neurological stereotaxic instrument
Regulation Number: 882.4560
Classification Product Code: HAW
Date Received: 07/23/2009
Decision Date: 11/17/2009
Regulation Medical Specialty: Neurology
Device Name: ROSA SURGICAL DEVICE, MODEL ROSA 1.1
Manufacturer: MEDTECH S.A.
Device Classification Name: neurological stereotaxic instrument
Regulation Number: 882.4560
Classification Product Code: HAW
Date Received: 07/23/2009
Decision Date: 11/17/2009
Regulation Medical Specialty: Neurology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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