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510(k) Data Aggregation
K Number
K992493Device Name
VIPON TAMPONManufacturer
Date Cleared
2000-11-06
(469 days)
Product Code
Regulation Number
884.5470Type
TraditionalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The Vipon tampon is indicated for females to absorb menstrual fluid and/or other vaginal discharge.
Device Description
Not Found
AI/ML Overview
This is a medical device approval letter from the FDA for the Vipon™ Menstrual Tampon. This document does not contain the information requested in your prompt regarding acceptance criteria and study details.
The letter confirms the device's substantial equivalence to legally marketed predicate devices and outlines general regulatory controls. It does not include performance data, study design, or ground truth methodology.
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