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FDA 510(k), K182811, gel-e Flex+
FDA 510(k), K182811, gel-e Flex+
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510(K) Number: K182811
Device Name: gel-e Flex+
Manufacturer: gel-e, Inc.
Device Classification Name: Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Regulation Number:
Classification Product Code: QSY
Date Received: 10/03/2018
Decision Date: 08/29/2019
Regulation Medical Specialty:
Device Name: gel-e Flex+
Manufacturer: gel-e, Inc.
Device Classification Name: Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Regulation Number:
Classification Product Code: QSY
Date Received: 10/03/2018
Decision Date: 08/29/2019
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. IMPORTANT: The FDA FOIA office operations are currently suspended. We are happy to make the request but do not know when we will receive a response. Learn more about Fast-Track Requests here.
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