
Bioplexus Corp.
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BIOSIL MEDICAL GRADE SILICONE SHEETING FOR OBSTETRICAL & GYNOCOLOGY APPLICATIONS is an FDA 510(k)-cleared medical device (K933827) manufactured by Bioplexus 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 June 29, 1994. Regulation: 8.