510(k) K100261

PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD by Tei Biosciences, Inc. — Product Code FRO

K100261 is an FDA 510(k) premarket notification submitted by Tei Biosciences, Inc. for the device "PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD". The FDA issued a decision of Substantially Equivalent on December 10, 2010. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Tei Biosciences, Inc. has at least 10 other 510(k) clearances on record.