
Medela, Inc.
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BASIC, MEDIAN, DOMINANT, AND VARIO is an FDA 510(k)-cleared medical device (K983552) manufactured by Medela, 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 January 6, 1999. Regulation: 8.