510(k) K041099

MODIFICATION TO SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIP by Spsmedical Supply Corp. — Product Code FRC

K041099 is an FDA 510(k) premarket notification submitted by Spsmedical Supply Corp. for the device "MODIFICATION TO SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIP". The FDA issued a decision of Substantially Equivalent on May 6, 2004. The device falls under product code FRC (Indicator, Biological Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Spsmedical Supply Corp. has at least 10 other 510(k) clearances on record.