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Found 3 results
510(k) Data Aggregation
(175 days)
BENTEC MEDICAL, INC.
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(48 days)
BENTEC MEDICAL, INC.
The catheter is designed to aid in controlling nasal hemorrhage due to trauma from injury. The device may also be used as a postoperative nasal packing following various intranasal surgical procedures, including septoplasty and rhinoplasty procedures.
Epistaxis Catheter
The provided text details an FDA 510(k) clearance letter for the Vyker Silicone Epistaxis Catheter and its intended use. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
Therefore, I cannot provide the requested information based on the input document. The document is solely an FDA clearance letter confirming substantial equivalence to a predicate device.
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(38 days)
BENTEC MEDICAL, INC.
Silicone Putty Ear Plugs are used to block water from entering the ear canal.
Silicone Putty Ear Plugs
This document is a 510(k) clearance letter for "Silicone Putty Ear Plugs" (K071517). It indicates that the device is substantially equivalent to legally marketed predicate devices. However, this type of regulatory correspondence does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.
Therefore, I cannot provide the requested information based solely on the provided text. The letter is a regulatory approval document, not a scientific study report.
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