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510(k) Data Aggregation
K Number
K212277Device Name
Tempo Tampon
Manufacturer
Date Cleared
2022-04-21
(275 days)
Product Code
Regulation Number
884.5470Why did this record match?
Applicant Name (Manufacturer) :
Dong-A Pharmaceutical Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Tempo Tampon is intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.
Device Description
The Tempo Tampon will be offered as a traditional unscented menstrual 100% cotton tampon consisting of an absorbent pledget, a withdrawal cord, and an applicator. The pledget is of the traditional cylindrical, bullet-like shape and the applicator has a standard rounded tip to ease insertion. Each tampon is individually wrapped and packaged in multi-unit containers for retail sale. It will be offered in two absorbances: Regular and Super.
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K Number
K212272Device Name
Tempo Natural Tampon
Manufacturer
Date Cleared
2021-09-17
(59 days)
Product Code
Regulation Number
884.5470Why did this record match?
Applicant Name (Manufacturer) :
Dong-A Pharmaceutical Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Tempo Natural Tampon is intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.
Device Description
The Tempo Natural Tampon will be offered as a traditional unscented menstrual 100% organic cotton tampon consisting of an absorbent pledget, a withdrawal cord, and an applicator. The pledget is of the traditional cylindrical, bullet-like shape and the applicator has a standard rounded tip to ease insertion. Each tampon is individually wrapped and packaged in multi-unit containers. It will be offered in two absorbances: Regular and Super.
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