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HGY — Pump, Breast, Non-Powered Class I

FDA Device Classification

Classification Details

Product Code
HGY
Device Class
Class I
Regulation Number
884.5150
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K101538philips electronics uk limitedHANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP)November 5, 2010
K032845first yearsEASY COMFORT DELUXE MANUAL BREAST PUMP, MODEL 1187April 5, 2004
K013226evenflo companyEVENFLO COMFORT EASE MANUAL BREAST PUMP KITDecember 20, 2001
K011519hollisterAMEDA HYGIENIKITAugust 15, 2001
K971231white river conceptsWHITE RIVER MINI MANUAL BREAST PUMPMay 19, 1997
K962828genesis industriesEVERT-ITFebruary 10, 1997
K952034medelaMEDELA'S FOOT PUMPSeptember 12, 1995
K952035avent americaNIPLETTEJuly 28, 1995
K925738white river (tm)WHITE RIVER MANUAL BREAST PUMPMay 4, 1994
K912355hollisterMOTHERS TOUCH ONE HAND BREAST PUMPDecember 10, 1993
K902552gerber productsGERBER PRECIOUS CARE ELECTRIC BREAST PUMPSeptember 26, 1990
K844297medelaSUPPLEMENTAL FEEDING SYSTEMFebruary 25, 1985
K850242crystal medical productsCRYSTAL MANUAL BREAST PUMPFebruary 25, 1985
K843544les entreprises bibiTHE BIBICURE SYS BREAST TONERJanuary 25, 1985
K840874kean-rody manufacturerRODY BREAST PUMPJuly 23, 1984
K840325monterey laboratoriesINFA COMPLETE BREAST PUMP & MILK STORAGMarch 5, 1984
K834399huntleigh technologyNEW MOTHER'S WAY-BREAST PUMPJanuary 17, 1984
K833835eklund andGENTLE FLOW BREAST PUMPNovember 28, 1983
K831929terayco intlBASIC BREAST PUMPSeptember 29, 1983
K832597gerber productsGERBER PRECISION CARE BREAST PUMPSeptember 12, 1983