510(k) K961309

POS-T-VAC ID-300 by Pos-T-Vac, Inc. — Product Code KZH

K961309 is an FDA 510(k) premarket notification submitted by Pos-T-Vac, Inc. for the device "POS-T-VAC ID-300". The FDA issued a decision of Substantially Equivalent on June 10, 1996. The device falls under product code KZH (Introducer, Syringe Needle), a Class II device regulated under 21 CFR 880.6920. Pos-T-Vac, Inc. has at least 10 other 510(k) clearances on record.