510(k) K930954

THE CABOT MEDICAL INSUL-SHETH VAGINAL SPECULUM COV by Cabot Medical Corp. — Product Code HIB

K930954 is an FDA 510(k) premarket notification submitted by Cabot Medical Corp. for the device "THE CABOT MEDICAL INSUL-SHETH VAGINAL SPECULUM COV". The FDA issued a decision of Substantially Equivalent on June 30, 1994. The device falls under product code HIB (Speculum, Vaginal, Nonmetal), a Class II device regulated under 21 CFR 884.4530. Cabot Medical Corp. has at least 10 other 510(k) clearances on record.