510(k) K895761

GENERAL ASPERATOR by Kolster Methods — Product Code JCX

K895761 is an FDA 510(k) premarket notification submitted by Kolster Methods for the device "GENERAL ASPERATOR". The FDA issued a decision of Substantially Equivalent on October 18, 1989. The device falls under product code JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered), a Class II device regulated under 21 CFR 878.4780. Kolster Methods has at least 2 other 510(k) clearances on record.