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FDA 510(k), K151244, Pre-Formed Guidewire
FDA 510(k), K151244, Pre-Formed Guidewire
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510(K) Number: K151244
Device Name: Pre-Formed Guidewire
Manufacturer: Mathew Pexa
Device Classification Name: Wire, Guide, Catheter
Regulation Number: DQX
Classification Product Code: 05/11/2015
Date Received: 06/11/2015
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: Pre-Formed Guidewire
Manufacturer: Mathew Pexa
Device Classification Name: Wire, Guide, Catheter
Regulation Number: DQX
Classification Product Code: 05/11/2015
Date Received: 06/11/2015
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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