
Orbit Biomedical, Inc.
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Orbit Subretinal Delivery System is an FDA 510(k)-cleared medical device (K182274) manufactured by Orbit Biomedical, Inc.. 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 November 19, 2018. Regulation: 8.

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