510(k) K950995

SENSICARE SYNTHETIC, SURGICAL GLOVE LINER by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code LYN

K950995 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "SENSICARE SYNTHETIC, SURGICAL GLOVE LINER". The FDA issued a decision of Substantially Equivalent on June 28, 1995. The device falls under product code LYN (Apparatus, Visual Reinforcement Audiometric), a Class II device regulated under 21 CFR 874.1050. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.