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510(k) Data Aggregation
K Number
K030056Device Name
WORRY-REMOVER IRRIGATOR
Manufacturer
Date Cleared
2003-04-22
(106 days)
Product Code
Regulation Number
884.5900Why did this record match?
Applicant Name (Manufacturer) :
CORISEN GROUP, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The WORRRY-REMOVER™ IRRIGATOR is designed for use as a vaginal douche apparatus for general feminine hygiene applications.
Device Description
The irrigating-bottle is hand-squeezed to force the cleaning solution to slowly and completely flow into the vaginal cavity. The one-way liquid valve permits the fluid to flow only from the bottle into the vaginal cavity but not back to the bottle, preventing contaminations of the solution and bottle. The one-way air valve permits air to flow into the bottle to prevent production of negative pressure within the bottle. The flow speed of the liquid is controlled by the user's hand. This system makes the process of vaginal irrigation much easier, neater, and more relaxing than using some other types of irrigators.
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