FDA.reportPublic FDA data

510(k) K944117

Device
AVENT NIPPLE SHIELD
Applicant
AVENT AMERICA, INC.
510(k) number
K944117
Product code
HFS  
Decision
Substantially Equivalent (SESE)
Decision date
1994-10-05
Date received
1994-08-23
Regulation
880.5630
Classification name
Shield, Nipple
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Address
1765 W. Cortland Ct., Unit L Addison IL US 60101 60101

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HFS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K944177BREAST SHELLO'Donnell, Byrne & Williams1994-10-05
K935340COMFORT PLUS NIPPLE SHIELDSMarshall Baby Products1994-01-21
K935341COMFORT PLUS BREAST SHELLSMarshall Baby Products1994-01-21
K930238BREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDSProlac, Inc.1993-08-16
K923577BREAST SHELLSMedela, Inc.1993-01-22
K864176GENTLE FEELMali, Inc.1986-11-04
K861608UNICARE BREAST SHELLSUnicare Medical Products, Inc.1986-07-15
K853176CANNON BABYSAFE NIPPLE SHIELDSMedela, Inc.1985-08-22
K840877ARGYLE ENTERNAL FEEDING BAG W/ADMINSherwood Medical Co.1984-06-28
K833450NUK BREAST SHIELDReliance Products Corp.1983-11-21
K811364AXICARE BREAST SHELLNeonatal Corp.1981-08-03

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases