510(k) K854922

AMSCO POLARIS SL by Amsco Co. — Product Code FSY

K854922 is an FDA 510(k) premarket notification submitted by Amsco Co. for the device "AMSCO POLARIS SL". The FDA issued a decision of Substantially Equivalent on January 24, 1986. The device falls under product code FSY (Light, Surgical, Ceiling Mounted), a Class II device regulated under 21 CFR 878.4580. Amsco Co. has at least 10 other 510(k) clearances on record.