FDA 510(k) Application Details - K021356

Device Classification Name Cup, Menstrual

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510(K) Number K021356
Device Name Cup, Menstrual
Applicant DIVA INTERNATIONAL INC
P.O. BOX 25089
1375 WEBER STREET E
KITCHENER ONTARIO N2A 4A5 CA
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Contact FRANCINE CHAMBERS
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Regulation Number 884.5400

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Classification Product Code HHE
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Date Received 04/29/2002
Decision Date 07/16/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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