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FDA 510(k), K103595, ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM
FDA 510(k), K103595, ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM
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510(K) Number: K103595
Device Name: ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM
Manufacturer: ACCLARENT, INC.
Device Classification Name: tube, tympanostomy
Regulation Number: 874.3880
Classification Product Code: ETD
Date Received: 12/08/2010
Decision Date: 04/01/2011
Regulation Medical Specialty: Ear Nose & Throat
Device Name: ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM
Manufacturer: ACCLARENT, INC.
Device Classification Name: tube, tympanostomy
Regulation Number: 874.3880
Classification Product Code: ETD
Date Received: 12/08/2010
Decision Date: 04/01/2011
Regulation Medical Specialty: Ear Nose & Throat
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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