FDA 510(k), K083358, LUBRICANO-ULTRASOUND

FDA 510(k), K083358, LUBRICANO-ULTRASOUND

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510(K) Number: K083358
Device Name: LUBRICANO-ULTRASOUND
Manufacturer: FARCO PHARMA GMBH
Device Classification Name: media, coupling, ultrasound
Regulation Number: 892.1570
Classification Product Code: MUI
Date Received: 10/14/2008
Decision Date: 01/09/2009
Regulation Medical Specialty: Radiology
  • 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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