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FDA 510(k), K192667, gel-e Flex+ gel OTC
FDA 510(k), K192667, gel-e Flex+ gel OTC
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510(K) Number: K192667
Device Name: gel-e Flex+ gel OTC
Manufacturer: gel-e, Inc.
Device Classification Name: Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Regulation Number:
Classification Product Code: QSY
Date Received: 09/25/2019
Decision Date: 10/25/2019
Regulation Medical Specialty:
Device Name: gel-e Flex+ gel OTC
Manufacturer: gel-e, Inc.
Device Classification Name: Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Regulation Number:
Classification Product Code: QSY
Date Received: 09/25/2019
Decision Date: 10/25/2019
Regulation Medical Specialty:
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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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