FDA 510(k), K220641, Barrigel Injectable Gel

FDA 510(k), K220641, Barrigel Injectable Gel

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510(K) Number: K220641
Device Name: Barrigel Injectable Gel
Manufacturer: David Goodnough
Device Classification Name: Hydrogel Spacer
Regulation Number: OVB
Classification Product Code: KXA
Date Received: 03/04/2022
Decision Date: 05/26/2022
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
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