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510(k) Data Aggregation
K Number
K961926Device Name
SANPOINT MENSTRUAL TAMPON
Manufacturer
Date Cleared
1996-07-15
(59 days)
Product Code
Regulation Number
884.5470Why did this record match?
Applicant Name (Manufacturer) :
SANPOINT AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
digital all-cotton tampons for feminine hygiene", and are of the same make and construction as the brand "Natracare" currently sold by our distributor Body Wise (UK) Ltd., Bristol, with office in Denver, USA, on the US and Canadian market, items which are approved by FDA.
The SanPoint product comprises a digital tampon of 100% peroxide bleached virgin cotton, and used to absorb menstrual and other vaginal discharges, when inserted in the vagina.
Device Description
The SanPoint product comprises a digital tampon of 100% peroxide bleached virgin cotton, and used to absorb menstrual and other vaginal discharges, when inserted in the vagina. The tampon also has a cotton string attached, enabling the user to remove the tampon after use.
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