510(k) K852535

E-Z P.E.G. W/PERCUTANEOUS ENDOSCOPY GASTROSTOMY by Tri-Med Specialties, Inc. — Product Code KNT

K852535 is an FDA 510(k) premarket notification submitted by Tri-Med Specialties, Inc. for the device "E-Z P.E.G. W/PERCUTANEOUS ENDOSCOPY GASTROSTOMY". The FDA issued a decision of Substantially Equivalent on October 17, 1985. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Tri-Med Specialties, Inc. has at least 10 other 510(k) clearances on record.