510(k) K801569

VAL-U-WRAP CSR WRAP by American Convertors Div., American Pharmaseal — Product Code FRG

K801569 is an FDA 510(k) premarket notification submitted by American Convertors Div., American Pharmaseal for the device "VAL-U-WRAP CSR WRAP". The FDA issued a decision of Substantially Equivalent on July 28, 1980. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. American Convertors Div., American Pharmaseal has at least 10 other 510(k) clearances on record.