Ceramax Skin Barrier Cream

• • Terminated Z-0763-2017 FDA Class II ·initiated 21 Nov 2016

  Firm became aware that professional samples of Ceramax are not meeting stability standards set for the product.

510(k) Number

K152055 ↗

FDA Product Code

FRO

Device Class

U

Advisory Committee

Unknown

FDA Decision

SESE Substantially Equivalent

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