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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 K852460
Device Name GENTLE EXPRESSIONS AUTOMATIC BREAST PUMP & FEED SY
Applicant
HEALTHTEAM
625 MONTROSE AVE.
SOUTH PLAINFIELD,  NJ  07080
Applicant Contact JOHN CHAMBERS
Correspondent
HEALTHTEAM
625 MONTROSE AVE.
SOUTH PLAINFIELD,  NJ  07080
Correspondent Contact JOHN CHAMBERS
Regulation Number884.5160
Classification Product Code
HGX  
Date Received06/10/1985
Decision Date 11/14/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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