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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Breast, Non-Powered
510(k) Number K925738
Device Name WHITE RIVER MANUAL BREAST PUMP
Applicant
White River (Tm)
23010 Lake Forest Dr., #310
Laguna Hills,  CA  92653
Applicant Contact CHRISTOPHER SUTTON
Correspondent
White River (Tm)
23010 Lake Forest Dr., #310
Laguna Hills,  CA  92653
Correspondent Contact CHRISTOPHER SUTTON
Regulation Number884.5150
Classification Product Code
HGY  
Date Received11/13/1992
Decision Date 05/04/1994
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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