510(k) K052085

STANDARD, SPECIAL, SPECIAL+, SNEEDLE B-TYPE AND SNEEDLE J-TYPE ACUPUNCTURE NEEDLES by Asia-Med GmbH and CO KG — Product Code MQX

K052085 is an FDA 510(k) premarket notification submitted by Asia-Med GmbH and CO KG for the device "STANDARD, SPECIAL, SPECIAL+, SNEEDLE B-TYPE AND SNEEDLE J-TYPE ACUPUNCTURE NEEDLES". The FDA issued a decision of Substantially Equivalent on October 14, 2005. 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.