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510(k) Data Aggregation
K Number
K211775Device Name
Cohitech Organic Cotton Non-Applicator Cottonlock Tampons
Manufacturer
Cotton High Tech S.L.
Date Cleared
2021-10-22
(135 days)
Product Code
HEB
Regulation Number
884.5470Why did this record match?
Applicant Name (Manufacturer) :
Cotton High Tech S.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
COHITECH Organic Cotton Non-Applicator Cottonlock Tampons (light, regular, super, and super plus absorbencies) are inserted into the vagina and used to absorb menstrual fluid.
Device Description
The subject device is a conventional unscented menstrual tampon consisting of an organic cotton absorbent pledget ("absorbent core"), completely surrounded by an organic cotton cover ("security veil") and with an organic cotton string ("withdrawal cord"). These tampons will be provided on four absorbencies: light (6g and under), regular (6-9g), super (9-12g) and super plus (12-15g). Each organic cotton non-applicator Cottonlock tampon is wrapped in a cellulose paper individual wrapper and packaged in sealed multi-unit containers for retail sale.
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K Number
K212479Device Name
Cohitech Reusable Tampon Applicator
Manufacturer
Cotton High Tech S.L.
Date Cleared
2021-10-08
(60 days)
Product Code
HEB, HIL
Regulation Number
884.5470Why did this record match?
Applicant Name (Manufacturer) :
Cotton High Tech S.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
COHITECH Reusable Tampon Applicator is intended to be used to insert a digital menstrual tampon into the vagina.
Device Description
The COHITECH Reusable Tampon Applicator is a non-sterile, single user, reusable medical device. It is intended to be sold on its own, without a pre-loaded tampon. The applicator requires the user to load the applicator with a legally marketed digital menstrual tampon. The use-life of the subject applicator is 4 years. The applicator requires the user to clean and disinfect the applicator before initial use, before longterm storage and at the end of the menstrual cycle, as well as to clean the device after each use.
The device consists of a polyethylene outer tampon housing and inner pusher, a polypropylene storage case, and a carrying case (optional).
This device is available in two sizes, one size for reqular and super digital tampons and another for super and super plus digital tampons. The total applicator length is 73.3 ± 0.2 mm for both sizes. The overall applicator diameter (outer housing and inner pusher) is 16 ± 0.1 mm for the regular/super digital tampon applicator and 19 ± 0.1 mm for the super/super plus digital tampon applicator. The applicator weight is 5.4 ± 0.2 for the regular/super tampon applicator and 5.7 ± 0.2 g for the super/super plus tampon applicator. The storage case weight is 7.9 ± 0.1 g and carrying case weight is 26.9 ± 0.1 g
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K Number
K152284Device Name
COHITECH NON APPLICATOR ORGANIC COTTON TAMPONS;COHITECH COMPACT APPLICATOR ORGANIC COTTON TAMPONS
Manufacturer
COTTON HIGH TECH S.L.
Date Cleared
2015-12-04
(114 days)
Product Code
HEB
Regulation Number
884.5470Why did this record match?
Applicant Name (Manufacturer) :
COTTON HIGH TECH S.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Cohitech Non Applicator Organic Cotton Tampons and Cohitech Compact Cotton Tampons (regular, super and super plus absorbencies) are inserted into the vagina and used to absorb menstrual fluid.
Device Description
The devices are conventional unscented menstrual tampons consisting of an absorbent pledget, with or without polyethylene/polyester cover and a withdrawal cord. These tampons will be provided as three absorbencies: regular, super and super plus.
Each non applicator organic cotton tampon is wrapped in an individual wrapper and packaged in sealed multi-unit containers for retail sale.
Each compact applicator organic cotton tampon is inserted into a plastic compact applicator and wrapped in an individual wrapper and packaged in sealed multi-unit containers for retail sale.
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