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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 K853326
Device Name WATER DRIVEN BREAST PUMP BY BABY NURSE
Applicant
Baby Nurse
4107 W. Sheridan
Phoenix,  AZ  85009
Applicant Contact GEORGE LEMLEY
Correspondent
Baby Nurse
4107 W. Sheridan
Phoenix,  AZ  85009
Correspondent Contact GEORGE LEMLEY
Regulation Number884.5160
Classification Product Code
HGX  
Date Received08/08/1985
Decision Date 11/19/1985
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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