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FDA 510(k), K070423, TR BAND
FDA 510(k), K070423, TR BAND
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510(K) Number: K070423
Device Name: TR BAND
Manufacturer: MARK UNTERREINER
Device Classification Name: Clamp, Vascular
Regulation Number: DXC
Classification Product Code: 02/13/2007
Date Received: 03/28/2007
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: TR BAND
Manufacturer: MARK UNTERREINER
Device Classification Name: Clamp, Vascular
Regulation Number: DXC
Classification Product Code: 02/13/2007
Date Received: 03/28/2007
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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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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