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Steve Islava
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CARE2 MEDICAL NEBULIZER, MODEL 101/102, 201/202 is an FDA 510(k)-cleared medical device (K091794) manufactured by Steve Islava. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 27, 2010. Regulation: 8.