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510(k) Data Aggregation
K Number
K101538Device Name
HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP)
Manufacturer
PHILIPS ELECTRONICS UK LIMITED
Date Cleared
2010-11-05
(155 days)
Product Code
HGY, HGW
Regulation Number
884.5150Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Philips Avent Manual Breast Pump is intended to express and collect milk from the breasts of a lactating woman.
Device Description
The Philips Avent Manual Breast Pump expresses and collects milk from the breast of a lactating woman. The device is designed to be reusable by a single user. The pump diaphragm is activated by a manual pivoting handle. The duckbill valve closes to prevent backflow and seal the device under negative pressure as the handle is depressed. The valve then relaxes to allow milk flow into the bottle between pump actuations. Pumping can only be performed on one breast at a time. The vacuum level can be adjusted to comfort by varying the speed and travel of the manual handle. The device is comprised of the manual breast pump parts and feeding bottle. The Philips Avent Manual Breast Pump operates in one mode - manual. In the manual mode, the user controls the frequency and level of vacuum by varying the stroke/cycle of the control handle lever. All milk-contacting and human tissue-contacting components are manufactured from materials that meet the appropriate regulations regarding food contact and/or biocompatibility.
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K Number
K032845Device Name
EASY COMFORT DELUXE MANUAL BREAST PUMP, MODEL 1187
Manufacturer
THE FIRST YEARS, INC.
Date Cleared
2004-04-05
(207 days)
Product Code
HGY
Regulation Number
884.5150Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Non-powered Breast Pump to express milk from the breast.
Device Description
Easy Comfort ™ Deluxe Manual Breast Pump
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K Number
K013226Device Name
EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT
Manufacturer
EVENFLO COMPANY, INC.
Date Cleared
2001-12-20
(84 days)
Product Code
HGY
Regulation Number
884.5150Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Like the predicate device, the proposed Eventlo Comfort East Pump . Like the predicate device to the latest of and one been a manage of any and is a non-powered, hand-operated (piston-type) suction device used to express milk from the breast of lactating women.
Device Description
non-powered, hand-operated (piston-type) suction device used to express milk from the breast of lactating women.
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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?
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Matched: '884.5150'
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
Not Found
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