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FDA 510(k), K202830, Axiostat Patch
FDA 510(k), K202830, Axiostat Patch
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510(K) Number: K202830
Device Name: Axiostat Patch
Manufacturer: Advamedica Inc.
Device Classification Name: Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Regulation Number:
Classification Product Code: QSY
Date Received: 09/25/2020
Decision Date: 04/15/2021
Regulation Medical Specialty:
Device Name: Axiostat Patch
Manufacturer: Advamedica Inc.
Device Classification Name: Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Regulation Number:
Classification Product Code: QSY
Date Received: 09/25/2020
Decision Date: 04/15/2021
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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