
Spectrum Medsystems Corp.
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UNI-GARD QUIK CATH(SIZES 8 FRENCH THROUGH 18)UG 10008,10010,10012,10014,10016,10018 is an FDA 510(k)-cleared medical device (K961906) manufactured by Spectrum Medsystems Corp.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on November 18, 1996. Regulation: 8.