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FDA 510(k), K121351, SINUS DILATION SYSTEM
FDA 510(k), K121351, SINUS DILATION SYSTEM
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510(K) Number: K121351
Device Name: SINUS DILATION SYSTEM
Manufacturer: ENTRIGUE SURGICAL, INC.
Device Classification Name: instrument, ent manual surgical
Regulation Number: 874.4420
Classification Product Code: LRC
Date Received: 05/04/2012
Decision Date: 08/29/2012
Regulation Medical Specialty: Ear Nose & Throat
Device Name: SINUS DILATION SYSTEM
Manufacturer: ENTRIGUE SURGICAL, INC.
Device Classification Name: instrument, ent manual surgical
Regulation Number: 874.4420
Classification Product Code: LRC
Date Received: 05/04/2012
Decision Date: 08/29/2012
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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