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510(k) Data Aggregation
(64 days)
TRITON HUDSON CHUCK ATTACHMENT
For use during surgical procedures to cut hard tissue, bone and soft tissue and to hold cranial perforators that have a standard Hudson fitting.
Hudson Chuck for Mednext TRITON Handpiece
This request cannot be fulfilled. The document provided is a 510(k) clearance letter from the FDA, a statement of intended use, and the device name. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. This type of information is typically found in the 510(k) submission itself or in published studies related to the device, neither of which are part of the provided text.
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