FDA 510(k), K001496, A.V. FISTULA NEEDLE

FDA 510(k), K001496, A.V. FISTULA NEEDLE

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510(K) Number: K001496
Device Name: A.V. FISTULA NEEDLE
Manufacturer: ARMAND HAMID
Device Classification Name: Needle, Fistula
Regulation Number: FIE
Classification Product Code: KXA
Date Received: 05/15/2000
Decision Date: 08/01/2000
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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