
Coloplast Corp.
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COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903) is an FDA 510(k)-cleared medical device (K971597) manufactured by Coloplast Corp.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 28, 1997. Regulation: 8.