510(k) K801554

STERILE CAST PADDING by Medi-Spec — Product Code HIX

K801554 is an FDA 510(k) premarket notification submitted by Medi-Spec for the device "STERILE CAST PADDING". The FDA issued a decision of Substantially Equivalent on August 4, 1980. The device falls under product code HIX (Maxwell Spot, Ac-Powered), a Class I device regulated under 21 CFR 886.1435. Medi-Spec has at least 7 other 510(k) clearances on record.