510(k) K020824

SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 AND 4238 by Boston Scientific Corp — Product Code FHN

K020824 is an FDA 510(k) premarket notification submitted by Boston Scientific Corp for the device "SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 AND 4238". The FDA issued a decision of Substantially Equivalent on April 12, 2002. The device falls under product code FHN (Ligator, Hemorrhoidal), a Class II device regulated under 21 CFR 876.4400. Boston Scientific Corp has at least 10 other 510(k) clearances on record.