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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 K971231
Device Name WHITE RIVER MINI MANUAL BREAST PUMP
Applicant
WHITE RIVER CONCEPTS
924 CALLE NEGOCIO, UNIT C
SAN CLEMENTE,  CA  92673
Applicant Contact E.J. Smith
Correspondent
WHITE RIVER CONCEPTS
924 CALLE NEGOCIO, UNIT C
SAN CLEMENTE,  CA  92673
Correspondent Contact E.J. Smith
Regulation Number884.5150
Classification Product Code
HGY  
Date Received04/03/1997
Decision Date 05/19/1997
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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