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FDA 510(k), K151117, Laparoscope Lens Shield Device
FDA 510(k), K151117, Laparoscope Lens Shield Device
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510(K) Number: K151117
Device Name: Laparoscope Lens Shield Device
Manufacturer: Medeon Biodesign, Inc
Device Classification Name: laparoscope, general & plastic surgery
Regulation Number: 876.1500
Classification Product Code: GCJ
Date Received: 04/27/2015
Decision Date: 08/20/2015
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: Laparoscope Lens Shield Device
Manufacturer: Medeon Biodesign, Inc
Device Classification Name: laparoscope, general & plastic surgery
Regulation Number: 876.1500
Classification Product Code: GCJ
Date Received: 04/27/2015
Decision Date: 08/20/2015
Regulation Medical Specialty: Gastroenterology/Urology
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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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