510(k) K213718

SOL-GUARD Safety Pull Button Collection Set by Sol-Millennium Medical, Inc. — Product Code JKA

K213718 is an FDA 510(k) premarket notification submitted by Sol-Millennium Medical, Inc. for the device "SOL-GUARD Safety Pull Button Collection Set". The FDA issued a decision of Substantially Equivalent on August 30, 2022. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Sol-Millennium Medical, Inc. has at least 10 other 510(k) clearances on record.