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FDA 510(k), K150020, Irritrol, EDS Combo-Rinse
FDA 510(k), K150020, Irritrol, EDS Combo-Rinse
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510(K) Number: K150020
Device Name: Irritrol, EDS Combo-Rinse
Manufacturer: ESSENTIAL DENTAL SYSTESM, INC.
Device Classification Name: cleanser, root canal
Regulation Number:
Classification Product Code: KJJ
Date Received: 01/06/2015
Decision Date: 02/25/2015
Regulation Medical Specialty:
Device Name: Irritrol, EDS Combo-Rinse
Manufacturer: ESSENTIAL DENTAL SYSTESM, INC.
Device Classification Name: cleanser, root canal
Regulation Number:
Classification Product Code: KJJ
Date Received: 01/06/2015
Decision Date: 02/25/2015
Regulation Medical Specialty:
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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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