FDA 510(k), K151830, Hummingbird Tympanostomy Tube

FDA 510(k), K151830, Hummingbird Tympanostomy Tube

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510(K) Number: K151830
Device Name: Hummingbird Tympanostomy Tube
Manufacturer: PRECEPTIS MEDICAL
Device Classification Name: tube, tympanostomy
Regulation Number: 874.3880
Classification Product Code: ETD
Date Received: 07/06/2015
Decision Date: 09/21/2015
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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