
Sil-Med Corp.
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ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT II is an FDA 510(k)-cleared medical device (K961392) manufactured by Sil-Med Corp.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 17, 1997. Regulation: 8.