510(k) K944083

MONOJECT(R) SAMPLETTE(R) COLLECTION TUBE by Sherwood Medical Co. — Product Code JKA

K944083 is an FDA 510(k) premarket notification submitted by Sherwood Medical Co. for the device "MONOJECT(R) SAMPLETTE(R) COLLECTION TUBE". The FDA issued a decision of Substantially Equivalent on May 26, 1995. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Sherwood Medical Co. has at least 10 other 510(k) clearances on record.