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FDA 510(k), K043527, RELIEVA SINUS BALLOON DILATION CATHETER
FDA 510(k), K043527, RELIEVA SINUS BALLOON DILATION CATHETER
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510(K) Number: K043527
Device Name: RELIEVA SINUS BALLOON DILATION CATHETER
Manufacturer: EXPLORAMED NC1, INC.
Device Classification Name: instrument, ent manual surgical
Regulation Number: 874.4420
Classification Product Code: LRC
Date Received: 12/21/2004
Decision Date: 04/05/2005
Regulation Medical Specialty: Ear Nose & Throat
Device Name: RELIEVA SINUS BALLOON DILATION CATHETER
Manufacturer: EXPLORAMED NC1, INC.
Device Classification Name: instrument, ent manual surgical
Regulation Number: 874.4420
Classification Product Code: LRC
Date Received: 12/21/2004
Decision Date: 04/05/2005
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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