FDA 510(k), K895614, CIVCO LATEX ULTRASOUND SHEATHS

FDA 510(k), K895614, CIVCO LATEX ULTRASOUND SHEATHS

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510(K) Number: K895614
Device Name: CIVCO LATEX ULTRASOUND SHEATHS
Manufacturer: BETTY FORINASH
Device Classification Name: System, Imaging, Pulsed Echo, Ultrasonic
Regulation Number: IYO
Classification Product Code: KXA
Date Received: 09/19/1989
Decision Date: 12/14/1989
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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