MACROSORBOS PROTECTIVE SHEET

MACROSORBOS PROTECTIVE SHEET is an FDA 510(k)-cleared medical device (K994158) manufactured by Macropore Biosurgery, 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 July 23, 2000. Regulation: 8.