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510(k) Data Aggregation
K Number
K080733Device Name
COTTONS 100% NATURAL COTTON TAMPONS
Manufacturer
COTTONS PTY, LTD
Date Cleared
2009-02-18
(341 days)
Product Code
HEB, CFR
Regulation Number
884.5470Why did this record match?
Applicant Name (Manufacturer) :
COTTONS PTY, LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Cottons Ltd, 100% Cotton Tampons are unscented, digital and applicator menstrual tampons for the absorption of menstrual fluid.
Device Description
The device is a 100% cotton, conventional unscented menstrual tampon. The device consists of a 100% cotton pledget, a withdrawal cord, with and without an applicator. Three absorbencies are offered as shown above. The cotton absorbent pledget consists of a pad of 100% cotton compressed into the traditional bullet shape. The absorbent pledget is overwrapped with cellophane. A cotton withdrawal cord is sewn to the pad.
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