510(k) K861307

DISPOSABLE NEEDLE COUNTER by Anago, Inc. — Product Code MMK

K861307 is an FDA 510(k) premarket notification submitted by Anago, Inc. for the device "DISPOSABLE NEEDLE COUNTER". The FDA issued a decision of Substantially Equivalent on May 2, 1986. The device falls under product code MMK (Container, Sharps), a Class II device regulated under 21 CFR 880.5570. Anago, Inc. has at least 10 other 510(k) clearances on record.