510(k) K991507

KANGNIAN BRAND ACUPUNCTURE NEEDLE by Helio Medical Supplies, Inc. — Product Code MQX

K991507 is an FDA 510(k) premarket notification submitted by Helio Medical Supplies, Inc. for the device "KANGNIAN BRAND ACUPUNCTURE NEEDLE". The FDA issued a decision of Substantially Equivalent on August 27, 1999. The device falls under product code MQX (Needle, Acupuncture, Single Use), a Class II device regulated under 21 CFR 880.5580. Helio Medical Supplies, Inc. has at least 10 other 510(k) clearances on record.