
Kirwan Surgical Products, Inc.
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DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY FOR MALIS SYSTEM CMC-II, MODEL 10-4601 is an FDA 510(k)-cleared medical device (K992218) manufactured by Kirwan Surgical Products, 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 July 29, 1999. Regulation: 8.