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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name cup, menstrual
510(k) Number K021356
Device Name THE DIVACUP MENSTRUAL SOLUTION
Applicant
DIVA INTERNATIONAL INC
P.O. BOX 25089
1375 WEBER STREET E
kitchener ontario,  CA n2a 4a5
Applicant Contact francine chambers
Correspondent
DIVA INTERNATIONAL INC
P.O. BOX 25089
1375 WEBER STREET E
kitchener ontario,  CA n2a 4a5
Correspondent Contact francine chambers
Regulation Number884.5400
Classification Product Code
HHE  
Date Received04/29/2002
Decision Date 07/16/2002
Decision substantially equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
statement statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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