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510(k) Data Aggregation
K Number
K052858Device Name
SOOTHIES GEL PADS
Manufacturer
Date Cleared
2006-02-09
(121 days)
Product Code
Regulation Number
880.5630Why did this record match?
Applicant Name (Manufacturer) :
PURONXY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Soothies Gel Pads are designed to enhance breastfeeding success by preventing friction between the nipple and the mother's clothing. They provide relief for sore and/or cracked nipples. Soothies are an absorbent and protective nipple shield. They provide a cooling sensation.
Device Description
Soothies are a nipple shield and are composed of glycerin, water and polyacrylamide, with a cloth backing. The gel pads soothe painful nipples and provide a cooling sensation.
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