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FDA 510(k), K080133, MOUNTABLE ENDOSCOPIC BLADE
FDA 510(k), K080133, MOUNTABLE ENDOSCOPIC BLADE
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510(K) Number: K080133
Device Name: MOUNTABLE ENDOSCOPIC BLADE
Manufacturer: A.M. SURGICAL, INC.
Device Classification Name: knife, surgical
Regulation Number: 878.4800
Classification Product Code: EMF
Date Received: 01/18/2008
Decision Date: 03/13/2008
Regulation Medical Specialty: General & Plastic Surgery
Device Name: MOUNTABLE ENDOSCOPIC BLADE
Manufacturer: A.M. SURGICAL, INC.
Device Classification Name: knife, surgical
Regulation Number: 878.4800
Classification Product Code: EMF
Date Received: 01/18/2008
Decision Date: 03/13/2008
Regulation Medical Specialty: General & Plastic Surgery
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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