510(k) K802998

PATIENT CARE DISPOSABLE INFANT SHIRTS by American Convertors Div., American Pharmaseal — Product Code KME

K802998 is an FDA 510(k) premarket notification submitted by American Convertors Div., American Pharmaseal for the device "PATIENT CARE DISPOSABLE INFANT SHIRTS". The FDA issued a decision of Substantially Equivalent on December 22, 1980. The device falls under product code KME (Bedding, Disposable, Medical), a Class I device regulated under 21 CFR 880.6060. American Convertors Div., American Pharmaseal has at least 10 other 510(k) clearances on record.