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Found 3 results
510(k) Data Aggregation
K Number
K970488Device Name
HYDROCHECK MICRO FILTER
Manufacturer
WHITE RIVER CONCEPTS
Date Cleared
1997-11-04
(267 days)
Product Code
HGX
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
WHITE RIVER CONCEPTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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
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K Number
K964679Device Name
WHITE RIVER AUTOMATIC BREAST PUMP
Manufacturer
WHITE RIVER CONCEPTS
Date Cleared
1997-06-10
(201 days)
Product Code
HGX
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
WHITE RIVER CONCEPTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The White River Automatic Breast Pump is a vacuum powered suction device used to express milk from the breast. It is intended to be used in the hospital setting where wall vacuum systems are available. The device consists of two parts: (1) a vacuum regulator, and; (2) a single patient use breast pump set, which ensures a consistent, clean method of emptying breast milk.
Device Description
The White River Automatic Breast Pump is a vacuum powered suction device used to express milk from the breast. It is intended to be used in the hospital setting where wall vacuum systems are available. The device consists of two parts: (1) a vacuum regulator, and; (2) a single patient use breast pump set, which ensures a consistent, clean method of emptying breast milk.
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K Number
K971231Device Name
WHITE RIVER MINI MANUAL BREAST PUMP
Manufacturer
WHITE RIVER CONCEPTS
Date Cleared
1997-05-19
(46 days)
Product Code
HGY
Regulation Number
884.5150Why did this record match?
Applicant Name (Manufacturer) :
WHITE RIVER CONCEPTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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
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