510(k) K240438

CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ® Sterilization Wrap (44 gsm) by Comercializadora Brever — Product Code FRG

K240438 is an FDA 510(k) premarket notification submitted by Comercializadora Brever for the device "CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ® Sterilization Wrap (44 gsm)". The FDA issued a decision of Substantially Equivalent on November 4, 2024. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850.