510(k) K811203

SAF SINGLE-USE AEROSOL FILTER by Sorensen Research — Product Code GCY

K811203 is an FDA 510(k) premarket notification submitted by Sorensen Research for the device "SAF SINGLE-USE AEROSOL FILTER". The FDA issued a decision of Substantially Equivalent on May 21, 1981. The device falls under product code GCY (Apparatus, Suction, Single Patient Use, Portable, Nonpowered), a Class I device regulated under 21 CFR 878.4680. Sorensen Research has at least 10 other 510(k) clearances on record.