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FDA 510(k), K132297, EM SINUS DILATION SYSTEM
FDA 510(k), K132297, EM SINUS DILATION SYSTEM
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510(K) Number: K132297
Device Name: EM SINUS DILATION SYSTEM
Manufacturer: MEDTRONIC XOMED, INC.
Device Classification Name: instrument, ent manual surgical
Regulation Number: 874.4420
Classification Product Code: LRC
Date Received: 07/24/2013
Decision Date: 11/05/2013
Regulation Medical Specialty: Ear Nose & Throat
Device Name: EM SINUS DILATION SYSTEM
Manufacturer: MEDTRONIC XOMED, INC.
Device Classification Name: instrument, ent manual surgical
Regulation Number: 874.4420
Classification Product Code: LRC
Date Received: 07/24/2013
Decision Date: 11/05/2013
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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