510(k) K761140

FRASER SWEATMAN'S DOUBLE MASK by Fraser Sweatman, Inc. — Product Code CBN

K761140 is an FDA 510(k) premarket notification submitted by Fraser Sweatman, Inc. for the device "FRASER SWEATMAN'S DOUBLE MASK". The FDA issued a decision of Substantially Equivalent on December 9, 1976. The device falls under product code CBN (Apparatus, Gas-Scavenging), a Class II device regulated under 21 CFR 868.5430. Fraser Sweatman, Inc. has at least 5 other 510(k) clearances on record.