510(k) K011808

ASIA-MED ACUPUNCTURE NEEDLES, (STANDARD, SPECIAL, COMPACT, APEX) by Asia-Med GmbH and CO KG — Product Code MQX

K011808 is an FDA 510(k) premarket notification submitted by Asia-Med GmbH and CO KG for the device "ASIA-MED ACUPUNCTURE NEEDLES, (STANDARD, SPECIAL, COMPACT, APEX)". The FDA issued a decision of Substantially Equivalent on July 10, 2001. 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.