BREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDS

K930238 · Prolac, Inc. · HFS · Aug 16, 1993 · General Hospital

Device Facts

Record IDK930238
Device NameBREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDS
ApplicantProlac, Inc.
Product CodeHFS · General Hospital
Decision DateAug 16, 1993
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 880.5630
Device ClassClass 1

Regulatory Classification

Identification

A nipple shield is a device consisting of a cover used to protect the nipple of a nursing woman. This generic device does not include nursing pads intended solely to protect the clothing of a nursing woman from milk.

Innolitics

Panel 1

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