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510(k) Data Aggregation
K Number
K971540Manufacturer
Date Cleared
1997-08-14
(108 days)
Product Code
Regulation Number
878.4400Type
TraditionalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
To transfer electrical current from generator to a surgical instrument
Device Description
Monopolar Cable
AI/ML Overview
This document is a 510(k) clearance letter from the FDA for a Monopolar Cable and does not contain the detailed information required to fulfill the request. The letter confirms substantial equivalence but does not describe acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert qualifications for a device's performance.
Therefore, I cannot provide the requested information based on the given text.
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