Search Results
Found 1 results
510(k) Data Aggregation
K Number
K182813Device Name
COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT
Manufacturer
Date Cleared
2019-03-15
(163 days)
Product Code
Regulation Number
884.5470Why did this record match?
Applicant Name (Manufacturer) :
Cotton High Tech, SL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
COHITECH Organic cotton cardboard applicator tampons light are unscented menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.
Device Description
The device is a conventional unscented menstrual tampon consisting of an absorbent pledget, a withdrawal cord and an applicator. It will be provided on light absorbency (6g and under). Each tampon is wrapped in an individual wrapper and packaged in sealed multi-unit containers for retail sale.
Ask a Question
Ask a specific question about this device
Page 1 of 1