510(k) K800511

SHIELD LUCKY CAP; BLOSSOM BOUFFANT CAP by American Convertors Div., American Pharmaseal — Product Code FYF

K800511 is an FDA 510(k) premarket notification submitted by American Convertors Div., American Pharmaseal for the device "SHIELD LUCKY CAP; BLOSSOM BOUFFANT CAP". The FDA issued a decision of Substantially Equivalent on April 16, 1980. The device falls under product code FYF (Cap, Surgical), a Class I device regulated under 21 CFR 878.4040. American Convertors Div., American Pharmaseal has at least 10 other 510(k) clearances on record.