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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 K000736
Device Name LA JOIE
Applicant
Goomi Ehwa, Inc.
P.O. Box 2123
Cupertino,  CA  95015
Applicant Contact MANOH PARK
Correspondent
Goomi Ehwa, Inc.
P.O. Box 2123
Cupertino,  CA  95015
Correspondent Contact MANOH PARK
Regulation Number884.5900
Classification Product Code
HED  
Date Received03/07/2000
Decision Date 08/08/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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