510(k) K961339

CARBO BRAND/VIVA BRAND ACUPUNCTURE NEEDLES by Helio Medical Supplies, Inc. — Product Code MQX

K961339 is an FDA 510(k) premarket notification submitted by Helio Medical Supplies, Inc. for the device "CARBO BRAND/VIVA BRAND ACUPUNCTURE NEEDLES". The FDA issued a decision of Substantially Equivalent on July 3, 1996. 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.