FDA 510(k), K931154, EVIS 200 SYSTEM

FDA 510(k), K931154, EVIS 200 SYSTEM

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510(K) Number: K931154
Device Name: EVIS 200 SYSTEM
Manufacturer: BARRY E SANDS
Device Classification Name: Bronchoscope (Flexible Or Rigid)
Regulation Number: EOQ
Classification Product Code: KXA
Date Received: 03/08/1993
Decision Date: 10/07/1993
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ear Nose & Throat
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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