510(k) K180661

SIGMA Sterilization Pouch and Roll by Sigma Medical Supplies Corp. — Product Code FRG

K180661 is an FDA 510(k) premarket notification submitted by Sigma Medical Supplies Corp. for the device "SIGMA Sterilization Pouch and Roll". The FDA issued a decision of Substantially Equivalent on Jun 5, 2018. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Sigma Medical Supplies Corp. has 2 other 510(k) clearances on record.