510(k) K901806

SUCTION ORA-SWAB(R) BRUSH KIT by Sage Products, Inc. — Product Code EIA

K901806 is an FDA 510(k) premarket notification submitted by Sage Products, Inc. for the device "SUCTION ORA-SWAB(R) BRUSH KIT". The FDA issued a decision of Substantially Equivalent (with conditions) on August 15, 1990. The device falls under product code EIA (Unit, Operative Dental), a Class I device regulated under 21 CFR 872.6640. Sage Products, Inc. has at least 10 other 510(k) clearances on record.