
Genzyme Corp.
Free shipping on orders over $99 · 30-day returns
SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXX is an FDA 510(k)-cleared medical device (K994328) manufactured by Genzyme Corp.. 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 March 1, 2000. Regulation: 8.