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510(k) Data Aggregation
K Number
K172842Device Name
GCE704 Breast PumpManufacturer
Date Cleared
2018-06-18
(272 days)
Product Code
Regulation Number
884.5160Type
TraditionalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The GCE704 Breast Pump is intended to express milk from the breasts of lactating women. The GCE704 Breast Pump is intended for a single user.
Device Description
Not Found
AI/ML Overview
The provided document is an FDA 510(k) clearance letter for the GCE704 Breast Pump. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. The letter confirms the device's substantial equivalence to a legally marketed predicate device and outlines regulatory compliance requirements.
Therefore, I cannot provide the requested information based on the given input.
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