FDA 510(k), K192007, TheraBase, TheraBase Ca
FDA 510(k), K192007, TheraBase, TheraBase Ca
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510(K) Number: K192007
Device Name: TheraBase, TheraBase Ca
Manufacturer: Bisco, Inc.
Device Classification Name: cement, dental
Regulation Number: 872.3275
Classification Product Code: EMA
Date Received: 07/29/2019
Decision Date: 03/17/2020
Regulation Medical Specialty: Dental
Device Name: TheraBase, TheraBase Ca
Manufacturer: Bisco, Inc.
Device Classification Name: cement, dental
Regulation Number: 872.3275
Classification Product Code: EMA
Date Received: 07/29/2019
Decision Date: 03/17/2020
Regulation Medical Specialty: Dental
- 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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