510(k) K180672

Sterilization Pouch/Roll Made with Tyvek by Sigma Medical Supplies Corporation — Product Code FRG

K180672 is an FDA 510(k) premarket notification submitted by Sigma Medical Supplies Corporation for the device "Sterilization Pouch/Roll Made with Tyvek". The FDA issued a decision of Substantially Equivalent on Jun 6, 2018. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Sigma Medical Supplies Corporation has 1 other 510(k) clearance on record.