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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Douche Apparatus, Vaginal, Therapeutic
510(k) Number K030056
Device Name WORRY-REMOVER IRRIGATOR
Applicant
Corisen Group, Ltd.
6537 Meadowbrook Ct.
West Chester,  OH  45069
Applicant Contact WEI N ZUO
Correspondent
Corisen Group, Ltd.
6537 Meadowbrook Ct.
West Chester,  OH  45069
Correspondent Contact WEI N ZUO
Regulation Number884.5900
Classification Product Code
HED  
Date Received01/06/2003
Decision Date 04/22/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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