510(k) K210135

PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing by 3M Healthcare Business Group — Product Code FRO

K210135 is an FDA 510(k) premarket notification submitted by 3M Healthcare Business Group for the device "PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing". The FDA issued a decision of Substantially Equivalent on Feb 24, 2022. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. 3M Healthcare Business Group has 4 other 510(k) clearances on record.