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510(k) Data Aggregation
K Number
K970488Device Name
HYDROCHECK MICRO FILTERManufacturer
Date Cleared
1997-11-04
(267 days)
Product Code
Regulation Number
884.5160Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Device Name :
HYDROCHECK MICRO FILTER
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The White River Hydrocheck Micro Filter is designed to remove particulate matter and prevent the passage of breast milk in vacuum lines and vacuum controlled breast pumps.
Device Description
Not Found
AI/ML Overview
The provided text is a 510(k) premarket notification letter from the FDA regarding the "Hydrocheck Micro Filter for Breast Pumps" and its "Indications for Use" statement. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the questions asked.
Therefore, I cannot fulfill your request using the provided text.
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