KSEA MEDI PACK

KSEA MEDI PACK is an FDA 510(k)-cleared medical device (K022490) manufactured by KARL STORZ Endoscopy-America, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 28, 2003. Regulation: 8.