MINIPACK 3100/3000 MODIFICATION

MINIPACK 3100/3000 MODIFICATION is an FDA 510(k)-cleared medical device (K934385) manufactured by Pace Tech, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 9, 1994. Regulation: 8.