510(k) K083295

SERIM DISINTEK GTA 2.1%, MODEL: 5164 by Serim Research Corp. — Product Code JOJ

K083295 is an FDA 510(k) premarket notification submitted by Serim Research Corp. for the device "SERIM DISINTEK GTA 2.1%, MODEL: 5164". The FDA issued a decision of Substantially Equivalent on March 16, 2009. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Serim Research Corp. has at least 10 other 510(k) clearances on record.