510(k) K922845

BASIC DRESSING CHANGE TRAY SMP 102A by Specialty Medical Products Co. — Product Code FRG

K922845 is an FDA 510(k) premarket notification submitted by Specialty Medical Products Co. for the device "BASIC DRESSING CHANGE TRAY SMP 102A". The FDA issued a decision of Substantially Equivalent (kit, denovo) on December 29, 1992. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Specialty Medical Products Co. has at least 3 other 510(k) clearances on record.