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FDA 510(k), K981575, TYMPANOSTOMY TUBE
FDA 510(k), K981575, TYMPANOSTOMY TUBE
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510(K) Number: K981575
Device Name: TYMPANOSTOMY TUBE
Manufacturer: Grace Medical, Inc.
Device Classification Name: tube, tympanostomy
Regulation Number: 874.3880
Classification Product Code: ETD
Date Received: 05/04/1998
Decision Date: 07/15/1998
Regulation Medical Specialty: Ear Nose & Throat
Device Name: TYMPANOSTOMY TUBE
Manufacturer: Grace Medical, Inc.
Device Classification Name: tube, tympanostomy
Regulation Number: 874.3880
Classification Product Code: ETD
Date Received: 05/04/1998
Decision Date: 07/15/1998
Regulation Medical Specialty: Ear Nose & Throat
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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