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HFS — Shield, Nipple Class I

FDA Device Classification

Classification Details

Product Code
HFS
Device Class
Class I
Regulation Number
880.5630
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K944177o'donnell, byrne and williamsBREAST SHELLOctober 5, 1994
K944117avent americaAVENT NIPPLE SHIELDOctober 5, 1994
K935341marshall baby productsCOMFORT PLUS BREAST SHELLSJanuary 21, 1994
K935340marshall baby productsCOMFORT PLUS NIPPLE SHIELDSJanuary 21, 1994
K930238prolacBREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDSAugust 16, 1993
K923577medelaBREAST SHELLSJanuary 22, 1993
K864176maliGENTLE FEELNovember 4, 1986
K861608unicare medical productsUNICARE BREAST SHELLSJuly 15, 1986
K853176medelaCANNON BABYSAFE NIPPLE SHIELDSAugust 22, 1985
K840877sherwood medicalARGYLE ENTERNAL FEEDING BAG W/ADMINJune 28, 1984
K833450reliance productsNUK BREAST SHIELDNovember 21, 1983
K811364neonatalAXICARE BREAST SHELLAugust 3, 1981