FDA 510(k), K003627, EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SET

FDA 510(k), K003627, EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SET

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510(K) Number: K003627
Device Name: EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SET
Manufacturer: ARMAND HAMID
Device Classification Name: Needle, Hypodermic, Single Lumen
Regulation Number: FMI
Classification Product Code: KXA
Date Received: 11/24/2000
Decision Date: 02/08/2001
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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