FDA 510(k), K061374, INTUITION INFUSION SETS

FDA 510(k), K061374, INTUITION INFUSION SETS

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510(K) Number: K061374
Device Name: INTUITION INFUSION SETS
Manufacturer: RABI GHARABLI
Device Classification Name: Set, Administration, Intravascular
Regulation Number: FPA
Classification Product Code: KXA
Date Received: 05/17/2006
Decision Date: 07/31/2006
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

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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