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510(k) Data Aggregation
K Number
K925501Device Name
NYLON COATED SPECULAManufacturer
Date Cleared
1997-06-13
(1687 days)
Product Code
Regulation Number
884.4530Type
TraditionalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Not Found
Device Description
Not Found
AI/ML Overview
The provided text is a 510(k) clearance letter from the FDA for "Nylon Coated Specula (Vaginal)". It is not a study report or a technical document detailing acceptance criteria and performance data for a medical device.
Therefore, I cannot extract the requested information (acceptance criteria, device performance, study details, sample sizes, expert qualifications, etc.) from this document. This letter merely states that the device is substantially equivalent to previously marketed devices and can be marketed, subject to general controls. It does not contain any of the technical or clinical performance data you've asked for.
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