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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 K870803
Device Name THE KEEPER
Applicant
THE KEEPER CO.
P.O. BOX 20023
CINCINNATI,  OH  45220
Applicant Contact LOU CRAWFORD
Correspondent
THE KEEPER CO.
P.O. BOX 20023
CINCINNATI,  OH  45220
Correspondent Contact LOU CRAWFORD
Regulation Number884.5400
Classification Product Code
HHE  
Date Received02/27/1987
Decision Date 05/06/1987
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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