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FDA 510(k), K150172, ACCLARENT SE Inflation Device
FDA 510(k), K150172, ACCLARENT SE Inflation Device
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510(K) Number: K150172
Device Name: ACCLARENT SE Inflation Device
Manufacturer: ACCLARENT, INC.
Device Classification Name: instrument, ent manual surgical
Regulation Number: 874.4420
Classification Product Code: LRC
Date Received: 01/26/2015
Decision Date: 04/07/2015
Regulation Medical Specialty: Ear Nose & Throat
Device Name: ACCLARENT SE Inflation Device
Manufacturer: ACCLARENT, INC.
Device Classification Name: instrument, ent manual surgical
Regulation Number: 874.4420
Classification Product Code: LRC
Date Received: 01/26/2015
Decision Date: 04/07/2015
Regulation Medical Specialty: Ear Nose & Throat
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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