510(k) K031716

SPECIAL+, S-NEEDLE J-TYPE, S-NEEDLE B-TYPE by Asia-Med GmbH and CO KG — Product Code MQX

K031716 is an FDA 510(k) premarket notification submitted by Asia-Med GmbH and CO KG for the device "SPECIAL+, S-NEEDLE J-TYPE, S-NEEDLE B-TYPE". The FDA issued a decision of Substantially Equivalent on July 10, 2003. The device falls under product code MQX (Needle, Acupuncture, Single Use), a Class II device regulated under 21 CFR 880.5580. Asia-Med GmbH and CO KG has at least 3 other 510(k) clearances on record.