510(k) K123481

AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE by Convatec, Inc. — Product Code FRO

K123481 is an FDA 510(k) premarket notification submitted by Convatec, Inc. for the device "AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE". The FDA issued a decision of Substantially Equivalent on June 6, 2013. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Convatec, Inc. has at least 10 other 510(k) clearances on record.