510(k) K851340

BLUE SEAL II STERILIZATION POUCH by American Sterilizer Co. — Product Code FRG

K851340 is an FDA 510(k) premarket notification submitted by American Sterilizer Co. for the device "BLUE SEAL II STERILIZATION POUCH". The FDA issued a decision of Substantially Equivalent on April 24, 1985. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. American Sterilizer Co. has at least 10 other 510(k) clearances on record.