510(k) K901369

GREEN LABEL BIOBRANE II AND RED LABEL BIOBRANE II by Sterling Drug, Inc. — Product Code KGN

K901369 is an FDA 510(k) premarket notification submitted by Sterling Drug, Inc. for the device "GREEN LABEL BIOBRANE II AND RED LABEL BIOBRANE II". The FDA issued a decision of Substantially Equivalent on June 5, 1990. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Sterling Drug, Inc. has at least 8 other 510(k) clearances on record.