GENERAL AND PLASTIC SURGERY PACKS

GENERAL AND PLASTIC SURGERY PACKS is an FDA 510(k)-cleared medical device (K951478) manufactured by Sterile Concepts, Inc.. 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 June 12, 1995. Regulation: 8.