510(k) K061517

PRECISION PRESS TACK / INTRADERM, SEVEN STAR AND ACUPUNCTURE NEEDLES; ALPHA AND FINE POINT ACUPUNCTURE NEEDLES by Prime Herbs Corporation — Product Code MQX

K061517 is an FDA 510(k) premarket notification submitted by Prime Herbs Corporation for the device "PRECISION PRESS TACK / INTRADERM, SEVEN STAR AND ACUPUNCTURE NEEDLES; ALPHA AND FINE POINT ACUPUNCTURE NEEDLES". The FDA issued a decision of Substantially Equivalent on November 22, 2006. The device falls under product code MQX (Needle, Acupuncture, Single Use), a Class II device regulated under 21 CFR 880.5580. Prime Herbs Corporation has at least 1 other 510(k) clearance on record.