GREATBATCH SCIENTIFIC MR COMPATIBLE SINUSCOPE

GREATBATCH SCIENTIFIC MR COMPATIBLE SINUSCOPE is an FDA 510(k)-cleared medical device (K971375) manufactured by Wilson Greatbatch Technologies, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 30, 1997. Regulation: 8.