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FDA 510(k), K183190, NuStat
FDA 510(k), K183190, NuStat
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510(K) Number: K183190
Device Name: NuStat
Manufacturer: Richard A. Kendall
Device Classification Name: Temporary, Internal Use Hemostatic
Regulation Number: POD
Classification Product Code: KXA
Date Received: 11/19/2018
Decision Date: 09/25/2019
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: NuStat
Manufacturer: Richard A. Kendall
Device Classification Name: Temporary, Internal Use Hemostatic
Regulation Number: POD
Classification Product Code: KXA
Date Received: 11/19/2018
Decision Date: 09/25/2019
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
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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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