510(k) K915170

PYMAH COLD STERILOG GLUTARALDEHYDE MONITOR by Pymah Corp. — Product Code MED

K915170 is an FDA 510(k) premarket notification submitted by Pymah Corp. for the device "PYMAH COLD STERILOG GLUTARALDEHYDE MONITOR". The FDA issued a decision of Substantially Equivalent on July 28, 1992. The device falls under product code MED (Sterilant, Medical Devices), a Class II device regulated under 21 CFR 880.6885. Pymah Corp. has at least 10 other 510(k) clearances on record.