FDA 510(k), K162759, KeraStat(R) Gel
FDA 510(k), K162759, KeraStat(R) Gel
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510(K) Number: K162759
Device Name: KeraStat(R) Gel
Manufacturer: KeraNetics, LLC.
Device Classification Name: wound dressing with animal-derived material(s)
Regulation Number:
Classification Product Code: KGN
Date Received: 09/30/2016
Decision Date: 06/02/2017
Regulation Medical Specialty:
Device Name: KeraStat(R) Gel
Manufacturer: KeraNetics, LLC.
Device Classification Name: wound dressing with animal-derived material(s)
Regulation Number:
Classification Product Code: KGN
Date Received: 09/30/2016
Decision Date: 06/02/2017
Regulation Medical Specialty: