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Ontex Bvba

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
6
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K191666Unscented W long plastic and cardboard applicator tamponsDecember 20, 2019
K162746Ontex and other proprietary namesMarch 3, 2017
K142786Ontex Unscented Tampons with Colored Plastic ApplicatorsJune 23, 2015
K132595ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONSApril 23, 2014
K132208ONTEX AND OTHERS PROPRIETARY NAMESApril 10, 2014
K122603ONTEX AND OTHER PROPRIETARY NAMESDecember 19, 2012