INTERSTRAND 125 & INTERSTRAND 103, MODEL NUMBERS 1251S AND 1031S

INTERSTRAND 125 & INTERSTRAND 103, MODEL NUMBERS 1251S AND 1031S is an FDA 510(k)-cleared medical device (K011155) manufactured by Ibt, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 11, 2001. Regulation: 8.