
Pollak (Intl.), Ltd.
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PEDIWET=GUAZE IMPREGNATED WITH PETROL is an FDA 510(k)-cleared medical device (K802007) manufactured by Pollak (Intl.), Ltd.. 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 September 25, 1980. Regulation: 8.