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FDA 510(k), K080788, VIVASCOPE SYSTEM, MODEL 1500, 3000
FDA 510(k), K080788, VIVASCOPE SYSTEM, MODEL 1500, 3000
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510(K) Number: K080788
Device Name: VIVASCOPE SYSTEM, MODEL 1500, 3000
Manufacturer: JAMES JOY
Device Classification Name: Light Based Imaging
Regulation Number: PSN
Classification Product Code: 03/20/2008
Date Received: 09/17/2008
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: VIVASCOPE SYSTEM, MODEL 1500, 3000
Manufacturer: JAMES JOY
Device Classification Name: Light Based Imaging
Regulation Number: PSN
Classification Product Code: 03/20/2008
Date Received: 09/17/2008
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
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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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