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FDA 510(k), K131282, NEXUS HEMORRHOID LIGATOR
FDA 510(k), K131282, NEXUS HEMORRHOID LIGATOR
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510(K) Number: K131282
Device Name: NEXUS HEMORRHOID LIGATOR
Manufacturer: PAUL DRYDEN
Device Classification Name: Ligator, Hemorrhoidal
Regulation Number: FHN
Classification Product Code: KXA
Date Received: 05/06/2013
Decision Date: 07/11/2013
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: NEXUS HEMORRHOID LIGATOR
Manufacturer: PAUL DRYDEN
Device Classification Name: Ligator, Hemorrhoidal
Regulation Number: FHN
Classification Product Code: KXA
Date Received: 05/06/2013
Decision Date: 07/11/2013
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
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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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