
Abbott Mfg., Inc.
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AXSYM GENTAMICIN is an FDA 510(k)-cleared medical device (K935376) manufactured by Abbott Mfg., Inc.. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 20, 1994. Regulation: 8.