
Augustine Biomedical & Design, LLC
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HOT DOG PATIENT WARMING MATTRESS SYSTEM, MODELS WCUB, M101, M102 AND M103 is an FDA 510(k)-cleared medical device (K092807) manufactured by Augustine Biomedical & Design, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 9, 2009. Regulation: 8.