510(k) K953102

BLOODBORNE PATHOGEN KIT by Certified Safety Mfg., Inc. — Product Code FXX

K953102 is an FDA 510(k) premarket notification submitted by Certified Safety Mfg., Inc. for the device "BLOODBORNE PATHOGEN KIT". The FDA issued a decision of Substantially Equivalent on December 11, 1995. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Certified Safety Mfg., Inc. has at least 10 other 510(k) clearances on record.