510(k) K132896

CJ-TYPE: METAL HANDLE WITH GUIDE TUBE, PJ-TYPE: PLASTIC HANDLE WITH GUIDE TUBE, CB-TYPE: METAL HANDLE WITHOUT GUIDE TUBE by Asia-Med GmbH and CO KG — Product Code MQX

K132896 is an FDA 510(k) premarket notification submitted by Asia-Med GmbH and CO KG for the device "CJ-TYPE: METAL HANDLE WITH GUIDE TUBE, PJ-TYPE: PLASTIC HANDLE WITH GUIDE TUBE, CB-TYPE: METAL HANDLE WITHOUT GUIDE TUBE". The FDA issued a decision of Substantially Equivalent on December 2, 2013. 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.