510(k) K915067

DISPOSABLE NEEDLE COUNTERS & DISPOSABLE SYSTEMS by American Medical Corp. — Product Code MMK

K915067 is an FDA 510(k) premarket notification submitted by American Medical Corp. for the device "DISPOSABLE NEEDLE COUNTERS & DISPOSABLE SYSTEMS". The FDA issued a decision of Substantially Equivalent on March 11, 1992. The device falls under product code MMK (Container, Sharps), a Class II device regulated under 21 CFR 880.5570. American Medical Corp. has at least 2 other 510(k) clearances on record.