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510(k) Data Aggregation
K Number
K971231Device Name
WHITE RIVER MINI MANUAL BREAST PUMPManufacturer
Date Cleared
1997-05-19
(46 days)
Product Code
Regulation Number
884.5150Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Device Name :
WHITE RIVER MINI MANUAL BREAST PUMP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The White River Mini Manual Breast Pump is used to sustain lactation, milk collection, relief of breast engorgement, and for relief of sore or cracked nipples.
Device Description
Not Found
AI/ML Overview
I am sorry, but this document contains no information about acceptance criteria or a study that proves a device meets acceptance criteria. It is a letter from the FDA regarding a 510(k) premarket notification for a "Mini Manual Breast Pump" and an "Indications for Use" statement for the same device.
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