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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 K964396
Device Name DOUBLE UP BREAST PUMP
Applicant
The Natural Choice Co., Inc.
1155 Chess Dr., Suite 115
Foster City,  CA  94404
Applicant Contact NANETTE NETTLES
Correspondent
The Natural Choice Co., Inc.
1155 Chess Dr., Suite 115
Foster City,  CA  94404
Correspondent Contact NANETTE NETTLES
Regulation Number884.5160
Classification Product Code
HGX  
Date Received11/04/1996
Decision Date 06/06/1997
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
Predetermined Change
Control Plan Authorized		 No
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