
Starcap Medical, LLC ( Dba Prism Medical & Design)
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ProteXsure Safety Capsule System is an FDA 510(k)-cleared medical device (K152597) manufactured by Starcap Medical, LLC ( Dba Prism Medical & Design). 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 June 7, 2016. Regulation: 8.

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