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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, powered
510(k) Number K964679
Device Name WHITE RIVER AUTOMATIC BREAST PUMP
Applicant
WHITE RIVER CONCEPTS
924 C CALLE NEGOCIO
SAN CLEMENTE,  CA  92673
Applicant Contact E.J. Smith
Correspondent
WHITE RIVER CONCEPTS
924 C CALLE NEGOCIO
SAN CLEMENTE,  CA  92673
Correspondent Contact E.J. Smith
Regulation Number884.5160
Classification Product Code
HGX  
Date Received11/21/1996
Decision Date 06/10/1997
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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