FDA 510(k) Application Details - K030056

Device Classification Name Douche Apparatus, Vaginal, Therapeutic

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510(K) Number K030056
Device Name Douche Apparatus, Vaginal, Therapeutic
Applicant CORISEN GROUP, LTD.
6537 MEADOWBROOK COURT
WEST CHESTER, OH 45069 US
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Contact WEI N ZUO
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Regulation Number 884.5900

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Classification Product Code HED
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Date Received 01/06/2003
Decision Date 04/22/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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