
Promedica Products, Inc.
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PETERS CARDIOFLON(TM) SUTURE is an FDA 510(k)-cleared medical device (K913101) manufactured by Promedica Products, 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 August 11, 1992. Regulation: 8.