KARL STORZ HEMPFLING DILATION SET

KARL STORZ HEMPFLING DILATION SET is an FDA 510(k)-cleared medical device (K954981) manufactured by KARL STORZ Endoscopy-America, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 3, 1995. Regulation: 8.