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FDA 510(k), K150453, TULA Iontophoresis System with Earset
FDA 510(k), K150453, TULA Iontophoresis System with Earset
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510(K) Number: K150453
Device Name: TULA Iontophoresis System with Earset
Manufacturer: ACCLARENT, INC.
Device Classification Name: device, iontophoresis, other uses
Regulation Number: 890.5525
Classification Product Code: EGJ
Date Received: 02/20/2015
Decision Date: 05/20/2015
Regulation Medical Specialty: Physical Medicine
Device Name: TULA Iontophoresis System with Earset
Manufacturer: ACCLARENT, INC.
Device Classification Name: device, iontophoresis, other uses
Regulation Number: 890.5525
Classification Product Code: EGJ
Date Received: 02/20/2015
Decision Date: 05/20/2015
Regulation Medical Specialty: Physical Medicine
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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