SHEATHES (NON-LATEX), STERILE

SHEATHES (NON-LATEX), STERILE is an FDA 510(k)-cleared medical device (K990175) manufactured by Sheathing Technologies, 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 April 20, 1999. Regulation: 8.