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• The Perf (Ommaya Style) Reservoir is intended as a means of gaining access to the cerebral ventricles by hypodermic puncture. It may be used for ventricular drainage.
• The Perf (Ommaya Style) Reservoir may be used to access the ventricles for the administration of chemotherapeutic agents and/or radioisotopes.

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This document is a 510(k) premarket notification letter from the FDA to Phoenix Biomedical Corporation regarding their "Perf (Ommaya Style) Reservoir." It is a regulatory approval document and does not contain information about acceptance criteria, device performance, or study details.

Therefore, I cannot provide the requested information from the provided text. The document outlines the FDA's decision that the device is substantially equivalent to legally marketed predicate devices and is thus cleared for marketing, subject to general controls provisions of the Act.

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