510(k) K952910

THE SWIRLER NEBULIZER by Amici, Inc. — Product Code CAF

K952910 is an FDA 510(k) premarket notification submitted by Amici, Inc. for the device "THE SWIRLER NEBULIZER". The FDA issued a decision of Substantially Equivalent on March 19, 1997. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Amici, Inc. has at least 7 other 510(k) clearances on record.