510(k) K897100

CENTURION VAGINAL SPECULUM by Tri-State Hospital Supply Corp. — Product Code HIC

K897100 is an FDA 510(k) premarket notification submitted by Tri-State Hospital Supply Corp. for the device "CENTURION VAGINAL SPECULUM". The FDA issued a decision of Substantially Equivalent on March 16, 1990. The device falls under product code HIC (Speculum, Vaginal, Nonmetal, Fiberoptic), a Class II device regulated under 21 CFR 884.4530. Tri-State Hospital Supply Corp. has at least 10 other 510(k) clearances on record.