
Coloplast A/S
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CONVEEN(R) SELF-SEALING URISHEATH MALE EXTER CATH is an FDA 510(k)-cleared medical device (K924407) manufactured by Coloplast A/S. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on September 22, 1992. Regulation: 8.

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