REXAM SELF-SEAL TYVEK POUCH

REXAM SELF-SEAL TYVEK POUCH is an FDA 510(k)-cleared medical device (K962600) manufactured by Rexam Medical Packaging, Inc.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 8, 1996. Regulation: 8.