
Ethicon Endo-Surgery, Inc.
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8 GAUGE MICROMARK II TISSUE MARKER, MODELS C1540 & C1535 is an FDA 510(k)-cleared medical device (K020276) manufactured by Ethicon Endo-Surgery, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 11, 2002. Regulation: 8.