510(k) K870051

SPAG-2 AEROSOL GENERATOR W/USE OF VIRAZOLE by Viratek, Inc. — Product Code CAF

K870051 is an FDA 510(k) premarket notification submitted by Viratek, Inc. for the device "SPAG-2 AEROSOL GENERATOR W/USE OF VIRAZOLE". The FDA issued a decision of Substantially Equivalent on October 6, 1987. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Viratek, Inc. has at least 4 other 510(k) clearances on record.