
Genzyme Surgical Product (Genzyme Biosurgery)
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BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE is an FDA 510(k)-cleared medical device (K991191) manufactured by Genzyme Surgical Product (Genzyme Biosurgery). 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 21, 1999. Regulation: 8.