DURABLUE STERILIZATION WRAP, MODEL NUMBERS CH100, CH200, CH300, CH400, CH500 AND CH600, STERRAD NX STERILIZATION

About This 510(k) Submission

K122507 is an FDA 510(k) clearance for the DURABLUE STERILIZATION WRAP, MODEL NUMBERS CH100, CH200, CH300, CH400, CH500 AND CH600, STERRAD NX STERILIZATION, a Wrap, Sterilization (Class II — Special Controls, product code FRG), submitted by Cardinal Health200, LLC (Waukegan, US). The FDA issued a Cleared decision on September 26, 2012, 40 days after receiving the submission on August 17, 2012. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.