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510(k) K912355

Device
MOTHERS TOUCH ONE HAND BREAST PUMP
Applicant
HOLLISTER, INC.
510(k) number
K912355
Product code
HGY  
Decision
Substantially Equivalent (SESE)
Decision date
1993-12-10
Date received
1991-05-28
Regulation
884.5150
Classification name
Pump, Breast, Non-powered
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JOHM F.LEMKER
Address
C/O Burdit,Radzius,Chartered 333 W.Wacker Dr. Chicago IL US 60606 60606

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HGY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K101538HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP)Philips Electronics UK Limited2010-11-05
K032845EASY COMFORT DELUXE MANUAL BREAST PUMP, MODEL 1187The First Years, Inc.2004-04-05
K013226EVENFLO COMFORT EASE MANUAL BREAST PUMP KITEvenflo Company, Inc.2001-12-20
K011519AMEDA HYGIENIKITHollister, Inc.2001-08-15
K971231WHITE RIVER MINI MANUAL BREAST PUMPWhite River Concepts1997-05-19
K962828EVERT-ITGenesis Industries, Inc.1997-02-10
K952034MEDELA'S FOOT PUMPMedela, Inc.1995-09-12
K952035NIPLETTEAvent America, Inc.1995-07-28
K925738WHITE RIVER MANUAL BREAST PUMPWhite River (Tm)1994-05-04
K902552GERBER PRECIOUS CARE ELECTRIC BREAST PUMPGerber Products Co.1990-09-26
K844297SUPPLEMENTAL FEEDING SYSTEMMedela, Inc.1985-02-25
K850242CRYSTAL MANUAL BREAST PUMPCrystal Medical Products, Inc.1985-02-25
K843544THE BIBICURE SYS BREAST TONERLes Entreprises Bibi, Inc.1985-01-25
K840874RODY BREAST PUMPKean-Rody Manufacturer1984-07-23
K840325INFA COMPLETE BREAST PUMP & MILK STORAGMonterey Laboratories, Inc.1984-03-05

Legacy Summary#

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FDA Review#

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