510(k) K061407

PRIMATRIX DERMAL REPAIR SCAFFOLD by Tei Biosciences, Inc. — Product Code KGN

K061407 is an FDA 510(k) premarket notification submitted by Tei Biosciences, Inc. for the device "PRIMATRIX DERMAL REPAIR SCAFFOLD". The FDA issued a decision of Substantially Equivalent on June 29, 2006. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Tei Biosciences, Inc. has at least 10 other 510(k) clearances on record.