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Dolomite Biotech Sdn Bhd
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SSAFE PLUS DISPOSABLE SAFETY SYRINGE, 3 CC AND 5 CC is an FDA 510(k)-cleared medical device (K070117) manufactured by Dolomite Biotech Sdn Bhd. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 5, 2007. Regulation: 8.

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