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510(k) K861608

Device
UNICARE BREAST SHELLS
Applicant
UNICARE MEDICAL PRODUCTS, INC.
510(k) number
K861608
Product code
HFS  
Decision
Substantially Equivalent (SESE)
Decision date
1986-07-15
Date received
1986-04-29
Regulation
880.5630
Classification name
Shield, Nipple
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
119 Montee De Liesse, Montreal Quebec H4t 1s6 CA

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HFS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K944117AVENT NIPPLE SHIELDAvent America, Inc.1994-10-05
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
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#

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FDA Review#

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