510(k) K820164

EMPTY STERILE CARPUJECT by Sterling Drug, Inc. — Product Code FMF

K820164 is an FDA 510(k) premarket notification submitted by Sterling Drug, Inc. for the device "EMPTY STERILE CARPUJECT". The FDA issued a decision of Substantially Equivalent on February 24, 1982. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Sterling Drug, Inc. has at least 8 other 510(k) clearances on record.