
Coombs Medical Device Consulting
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ESTECH PERCUTANEOUS INSERTION DILATOR KIT is an FDA 510(k)-cleared medical device (K070749) manufactured by Coombs Medical Device Consulting. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 23, 2007. Regulation: 8.