STOP U (PACKED BLACK USA); STOP U (PACKED WHITE USA)

STOP U (PACKED BLACK USA); STOP U (PACKED WHITE USA) is an FDA 510(k)-cleared medical device (K140255) manufactured by Pollogen, Ltd.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 13, 2014. Regulation: 8.