FDA 510(k), K062672, GRACE MEDICAL PC COATED TYMPANOSTOMY TUBES

FDA 510(k), K062672, GRACE MEDICAL PC COATED TYMPANOSTOMY TUBES

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510(K) Number: K062672
Device Name: GRACE MEDICAL PC COATED TYMPANOSTOMY TUBES
Manufacturer: Grace Medical, Inc.
Device Classification Name: tube, tympanostomy
Regulation Number: 874.3880
Classification Product Code: ETD
Date Received: 09/08/2006
Decision Date: 10/24/2006
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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