510(k) K951808

MED-TEC REDI-FOAM by Medtec, Inc. — Product Code IYE

K951808 is an FDA 510(k) premarket notification submitted by Medtec, Inc. for the device "MED-TEC REDI-FOAM". The FDA issued a decision of Substantially Equivalent on July 6, 1995. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Medtec, Inc. has at least 10 other 510(k) clearances on record.