510(k) K132198

ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI by Ceremed , Inc. — Product Code KHJ

K132198 is an FDA 510(k) premarket notification submitted by Ceremed , Inc. for the device "ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI". The FDA issued a decision of Substantially Equivalent on September 12, 2013. The device falls under product code KHJ (Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)), a Class II device regulated under 21 CFR 874.3620. Ceremed , Inc. has at least 10 other 510(k) clearances on record.