510(k) K821394

SUTURE-SAFE 40 ADHESIVE NEEDLE COUNTER by Kleen Test Products — Product Code MMK

K821394 is an FDA 510(k) premarket notification submitted by Kleen Test Products for the device "SUTURE-SAFE 40 ADHESIVE NEEDLE COUNTER". The FDA issued a decision of Substantially Equivalent on June 3, 1982. The device falls under product code MMK (Container, Sharps), a Class II device regulated under 21 CFR 880.5570. Kleen Test Products has at least 10 other 510(k) clearances on record.