510(k) K874296

INFECTION CONTROL GOGGLE (TSE FONG)/STER/NON-STER by Ulti-Med Intl., Inc. — Product Code FXX

K874296 is an FDA 510(k) premarket notification submitted by Ulti-Med Intl., Inc. for the device "INFECTION CONTROL GOGGLE (TSE FONG)/STER/NON-STER". The FDA issued a decision of Substantially Equivalent on January 7, 1988. The device falls under product code FXX (Mask, Surgical), a Class II device regulated under 21 CFR 878.4040. Ulti-Med Intl., Inc. has at least 10 other 510(k) clearances on record.